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Effect of Efpeglenatide on Cardiovascular Outcomes (AMPLITUDE-O)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Efpeglenatide (SAR439977)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage.
  • Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor.
  • Female participants agreed to follow contraceptive guidance.
  • Signed written informed consent.

Exclusion criteria:

  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
  • History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.
  • Personal or family history of medullary thyroid cancer.
  • Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or diastolic blood pressure >100 mmHg).
  • Hospitalization for hypertensive emergency within 3 months prior to randomization.
  • Planned coronary procedure or surgery after randomization.
  • No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.
  • Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.
  • Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
  • Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.
  • Antihyperglycemic treatment had not been stable within 3 months prior to screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 8400032
  • Investigational Site Number 8400014
  • Investigational Site Number 8400012
  • Investigational Site Number 8400046
  • Investigational Site Number 8400022
  • Investigational Site Number 8400065
  • Investigational Site Number 8400060
  • Investigational Site Number 8400084
  • Investigational Site Number 8400002
  • Investigational Site Number 8400085
  • Investigational Site Number 8400082
  • Investigational Site Number 8400025
  • Investigational Site Number 8400064
  • Investigational Site Number 8400019
  • Investigational Site Number 8400023
  • Investigational Site Number 8400091
  • Investigational Site Number 8400040
  • Investigational Site Number 8400073
  • Investigational Site Number 8400011
  • Investigational Site Number 8400017
  • Investigational Site Number 8400042
  • Investigational Site Number 8400027
  • Investigational Site Number 8400051
  • Investigational Site Number 8400041
  • Investigational Site Number 8400059
  • Investigational Site Number 8400006
  • Investigational Site Number 8400008
  • Investigational Site Number 8400081
  • Investigational Site Number 8400095
  • Investigational Site Number 8400070
  • Investigational Site Number 8400036
  • Investigational Site Number 8400030
  • Investigational Site Number 8400074
  • Investigational Site Number 8400077
  • Investigational Site Number 8400043
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  • Investigational Site Number 8400079
  • Investigational Site Number 8400013
  • Investigational Site Number 8400047
  • Investigational Site Number 8400001
  • Investigational Site Number 8400061
  • Investigational Site Number 8400010
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  • Investigational Site Number 8400024
  • Investigational Site Number 8400045
  • Investigational Site Number 8400071
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  • Investigational Site Number 8400086
  • Investigational Site Number 8400037
  • Investigational Site Number 8400087
  • Investigational Site Number 8400018
  • Investigational Site Number 8400056
  • Investigational Site Number 8400076
  • Investigational Site Number 8400007
  • Investigational Site Number 8400093
  • Investigational Site Number 8400094
  • Investigational Site Number 8400029
  • Investigational Site Number 8400031
  • Investigational Site Number 8400078
  • Investigational Site Number 8400072
  • Investigational Site Number 8400067
  • Investigational Site Number 8400096
  • Investigational Site Number 8400021
  • Investigational Site Number 8400015
  • Investigational Site Number 8400063
  • Investigational Site Number 8400044
  • Investigational Site Number 8400016
  • Investigational Site Number 8400009
  • Investigational Site Number 8400055
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  • Investigational Site Number 8400069
  • Investigational Site Number 8400089
  • Investigational Site Number 8400092
  • Investigational Site Number 8400033
  • Investigational Site Number 8400039
  • Investigational Site Number 8400052
  • Investigational Site Number 8400049
  • Investigational Site Number 0320009
  • Investigational Site Number 0320002
  • Investigational Site Number 0320013
  • Investigational Site Number 0320010
  • Investigational Site Number 0320005
  • Investigational Site Number 0320008
  • Investigational Site Number 0320001
  • Investigational Site Number 0320004
  • Investigational Site Number 0320012
  • Investigational Site Number 0320011
  • Investigational Site Number 0320007
  • Investigational Site Number 0320006
  • Investigational Site Number 0320015
  • Investigational Site Number 0320017
  • Investigational Site Number 0320003
  • Investigational Site Number 0320018
  • Investigational Site Number 0320016
  • Investigational Site Number 0320014
  • Investigational Site Number 1000011
  • Investigational Site Number 1000014
  • Investigational Site Number 1000017
  • Investigational Site Number 1000007
  • Investigational Site Number 1000013
  • Investigational Site Number 1000010
  • Investigational Site Number 1000008
  • Investigational Site Number 1000002
  • Investigational Site Number 1000012
  • Investigational Site Number 1000003
  • Investigational Site Number 1000001
  • Investigational Site Number 1000005
  • Investigational Site Number 1000006
  • Investigational Site Number 1000009
  • Investigational Site Number 1000016
  • Investigational Site Number 1240001
  • Investigational Site Number 1240002
  • Investigational Site Number 1240018
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  • Investigational Site Number 1240007
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  • Investigational Site Number 1240004
  • Investigational Site Number 1240005
  • Investigational Site Number 1240011
  • Investigational Site Number 1240025
  • Investigational Site Number 1240028
  • Investigational Site Number 1240029
  • Investigational Site Number 1240008
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  • Investigational Site Number 1240014
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  • Investigational Site Number 3480012
  • Investigational Site Number 3480011
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  • Investigational Site Number 3480005
  • Investigational Site Number 3480001
  • Investigational Site Number 3480006
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  • Investigational Site Number 3480008
  • Investigational Site Number 3480007
  • Investigational Site Number 3480004
  • Investigational Site Number 3560001
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  • Investigational Site Number 3560003
  • Investigational Site Number 3560009
  • Investigational Site Number 3560010
  • Investigational Site Number 3560005
  • Investigational Site Number 3560004
  • Investigational Site Number 3800006
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  • Investigational Site Number 4840004
  • Investigational Site Number 4840007
  • Investigational Site Number 4840009
  • Investigational Site Number 4840013
  • Investigational Site Number 4840014
  • Investigational Site Number 4840002
  • Investigational Site Number 4840016
  • Investigational Site Number 4840015
  • Investigational Site Number 4840006
  • Investigational Site Number 4840003
  • Investigational Site Number 4840005
  • Investigational Site Number 4840011
  • Investigational Site Number 4840010
  • Investigational Site Number 4840001
  • Investigational Site Number 5780002
  • Investigational Site Number 5780001
  • Investigational Site Number 5780003
  • Investigational Site Number 6040007
  • Investigational Site Number 6040004
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  • Investigational Site Number 6040002
  • Investigational Site Number 6160017
  • Investigational Site Number 6160018
  • Investigational Site Number 6160015
  • Investigational Site Number 6160016
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  • Investigational Site Number 6160011
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  • Investigational Site Number 6160007
  • Investigational Site Number 6160009
  • Investigational Site Number 6160014
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  • Investigational Site Number 6160004
  • Investigational Site Number 6420007
  • Investigational Site Number 6420001
  • Investigational Site Number 6420011
  • Investigational Site Number 6420009
  • Investigational Site Number 6420012
  • Investigational Site Number 6420005
  • Investigational Site Number 6420010
  • Investigational Site Number 6420008
  • Investigational Site Number 6420002
  • Investigational Site Number 6420003
  • Investigational Site Number 6430018
  • Investigational Site Number 6430014
  • Investigational Site Number 6430001
  • Investigational Site Number 6430017
  • Investigational Site Number 6430004
  • Investigational Site Number 6430005
  • Investigational Site Number 6430002
  • Investigational Site Number 6430015
  • Investigational Site Number 6430009
  • Investigational Site Number 6430019
  • Investigational Site Number 6430006
  • Investigational Site Number 6430012
  • Investigational Site Number 6430003
  • Investigational Site Number 6430020
  • Investigational Site Number 6430010
  • Investigational Site Number 6430011
  • Investigational Site Number 6430013
  • Investigational Site Number 6430016
  • Investigational Site Number 6880001
  • Investigational Site Number 6880002
  • Investigational Site Number 6880003
  • Investigational Site Number 6880005
  • Investigational Site Number 6880004
  • Investigational Site Number 6880006
  • Investigational Site Number 7030007
  • Investigational Site Number 7030001
  • Investigational Site Number 7030004
  • Investigational Site Number 7030003
  • Investigational Site Number 7030009
  • Investigational Site Number 7030010
  • Investigational Site Number 7030006
  • Investigational Site Number 7030005
  • Investigational Site Number 7030008
  • Investigational Site Number 7030011
  • Investigational Site Number 7030002
  • Investigational Site Number 7030012
  • Investigational Site Number 7100007
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  • Investigational Site Number 7240008
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  • Investigational Site Number 7240009
  • Investigational Site Number 7240007
  • Investigational Site Number 7240010
  • Investigational Site Number 7240001
  • Investigational Site Number 7240006
  • Investigational Site Number 7240011
  • Investigational Site Number 7240005
  • Investigational Site Number 7240003
  • Investigational Site Number 7240013
  • Investigational Site Number 7240004
  • Investigational Site Number 7240014
  • Investigational Site Number 7520006
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  • Investigational Site Number 7520002
  • Investigational Site Number 7520005
  • Investigational Site Number 7520001
  • Investigational Site Number 7920005
  • Investigational Site Number 7920010
  • Investigational Site Number 7920012
  • Investigational Site Number 7920015
  • Investigational Site Number 7920002
  • Investigational Site Number 7920013
  • Investigational Site Number 7920001
  • Investigational Site Number 7920006
  • Investigational Site Number 7920011
  • Investigational Site Number 7920014
  • Investigational Site Number 7920007
  • Investigational Site Number 7920009
  • Investigational Site Number 8040006
  • Investigational Site Number 8040009
  • Investigational Site Number 8040001
  • Investigational Site Number 8040003
  • Investigational Site Number 8040002
  • Investigational Site Number 8040007
  • Investigational Site Number 8040008
  • Investigational Site Number 8040004
  • Investigational Site Number 8040005

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Efpeglenatide 4 mg

Efpeglenatide 6 mg

Arm Description

Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.

Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.

Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.

Outcomes

Primary Outcome Measures

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis
All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

Secondary Outcome Measures

Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis
All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event
All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.
Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint
Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (>) 300, as measured in mg of albumin to grams of creatinine, or >33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

Full Information

First Posted
April 5, 2018
Last Updated
September 16, 2021
Sponsor
Sanofi
Collaborators
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03496298
Brief Title
Effect of Efpeglenatide on Cardiovascular Outcomes
Acronym
AMPLITUDE-O
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to cancel TRIAL, not related to safety concern
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters: 3-point MACE. Expanded CV outcome. Composite outcome of new or worsening nephropathy. To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
Detailed Description
The study duration per participant was up to approximately 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4076 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.
Arm Title
Efpeglenatide 4 mg
Arm Type
Experimental
Arm Description
Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.
Arm Title
Efpeglenatide 6 mg
Arm Type
Experimental
Arm Description
Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.
Intervention Type
Drug
Intervention Name(s)
Efpeglenatide (SAR439977)
Intervention Description
Pharmaceutical form: Solution for injection, Route of administration: SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: SC
Primary Outcome Measure Information:
Title
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis
Description
All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time Frame
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Secondary Outcome Measure Information:
Title
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis
Description
All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time Frame
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Title
Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event
Description
All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.
Time Frame
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Title
Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint
Description
Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (>) 300, as measured in mg of albumin to grams of creatinine, or >33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time Frame
From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage. Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor. Female participants agreed to follow contraceptive guidance. Signed written informed consent. Exclusion criteria: Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting. History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening. Personal or family history of medullary thyroid cancer. Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or diastolic blood pressure >100 mmHg). Hospitalization for hypertensive emergency within 3 months prior to randomization. Planned coronary procedure or surgery after randomization. No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization. Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study. Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening. Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening. Antihyperglycemic treatment had not been stable within 3 months prior to screening. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8400032
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Investigational Site Number 8400014
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Investigational Site Number 8400012
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Investigational Site Number 8400046
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Investigational Site Number 8400022
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Investigational Site Number 8400065
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Investigational Site Number 8400060
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigational Site Number 8400084
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Investigational Site Number 8400002
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Investigational Site Number 8400085
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Investigational Site Number 8400082
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Investigational Site Number 8400025
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Investigational Site Number 8400064
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Investigational Site Number 8400019
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Investigational Site Number 8400023
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708-3346
Country
United States
Facility Name
Investigational Site Number 8400091
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Investigational Site Number 8400040
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Investigational Site Number 8400073
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Investigational Site Number 8400011
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Investigational Site Number 8400017
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Investigational Site Number 8400042
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
Investigational Site Number 8400027
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Investigational Site Number 8400051
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Investigational Site Number 8400041
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 8400059
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Investigational Site Number 8400006
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210-1359
Country
United States
Facility Name
Investigational Site Number 8400008
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigational Site Number 8400081
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 8400095
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Investigational Site Number 8400070
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Investigational Site Number 8400036
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Investigational Site Number 8400030
City
New Albany
State/Province
Indiana
ZIP/Postal Code
46113
Country
United States
Facility Name
Investigational Site Number 8400074
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Investigational Site Number 8400077
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Investigational Site Number 8400043
City
Paris
State/Province
Kentucky
ZIP/Postal Code
40361
Country
United States
Facility Name
Investigational Site Number 8400034
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Investigational Site Number 8400079
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Investigational Site Number 8400013
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Investigational Site Number 8400047
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Investigational Site Number 8400001
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Investigational Site Number 8400061
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532-3447
Country
United States
Facility Name
Investigational Site Number 8400010
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Investigational Site Number 8400005
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Investigational Site Number 8400024
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Investigational Site Number 8400045
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Investigational Site Number 8400071
City
Billings
State/Province
Montana
ZIP/Postal Code
59103
Country
United States
Facility Name
Investigational Site Number 8400028
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405-4507
Country
United States
Facility Name
Investigational Site Number 8400086
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Investigational Site Number 8400037
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Investigational Site Number 8400087
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Investigational Site Number 8400018
City
Bronx
State/Province
New York
ZIP/Postal Code
00000
Country
United States
Facility Name
Investigational Site Number 8400056
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Investigational Site Number 8400076
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834-5704
Country
United States
Facility Name
Investigational Site Number 8400007
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Investigational Site Number 8400093
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Investigational Site Number 8400094
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Investigational Site Number 8400029
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Investigational Site Number 8400031
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Investigational Site Number 8400078
City
Lorain
State/Province
Ohio
ZIP/Postal Code
44053
Country
United States
Facility Name
Investigational Site Number 8400072
City
Bend
State/Province
Oregon
ZIP/Postal Code
97702
Country
United States
Facility Name
Investigational Site Number 8400067
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009-1957
Country
United States
Facility Name
Investigational Site Number 8400096
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Investigational Site Number 8400021
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Investigational Site Number 8400015
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigational Site Number 8400063
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Investigational Site Number 8400044
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Investigational Site Number 8400016
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Investigational Site Number 8400009
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Investigational Site Number 8400055
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78814
Country
United States
Facility Name
Investigational Site Number 8400097
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 8400088
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Investigational Site Number 8400058
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Investigational Site Number 8400069
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Investigational Site Number 8400089
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 8400092
City
Richmond
State/Province
Texas
ZIP/Postal Code
77469
Country
United States
Facility Name
Investigational Site Number 8400033
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Investigational Site Number 8400039
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Investigational Site Number 8400052
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Investigational Site Number 8400049
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54220
Country
United States
Facility Name
Investigational Site Number 0320009
City
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Investigational Site Number 0320002
City
Caba
ZIP/Postal Code
1120
Country
Argentina
Facility Name
Investigational Site Number 0320013
City
Caba
ZIP/Postal Code
1425DES
Country
Argentina
Facility Name
Investigational Site Number 0320010
City
Caba
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Investigational Site Number 0320005
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Investigational Site Number 0320008
City
Capital Federal
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Investigational Site Number 0320001
City
Capital Federal
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Investigational Site Number 0320004
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Investigational Site Number 0320012
City
Corrientes
ZIP/Postal Code
W3410AVV
Country
Argentina
Facility Name
Investigational Site Number 0320011
City
Godoy Cruz
ZIP/Postal Code
M5501ARP
Country
Argentina
Facility Name
Investigational Site Number 0320007
City
Mar Del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Investigational Site Number 0320006
City
Merlo
ZIP/Postal Code
B1722COV
Country
Argentina
Facility Name
Investigational Site Number 0320015
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigational Site Number 0320017
City
Rosario
ZIP/Postal Code
S2002OJP
Country
Argentina
Facility Name
Investigational Site Number 0320003
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Investigational Site Number 0320018
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Investigational Site Number 0320016
City
San Isidro
ZIP/Postal Code
B1642DCB
Country
Argentina
Facility Name
Investigational Site Number 0320014
City
Santa Rosa
Country
Argentina
Facility Name
Investigational Site Number 1000011
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Investigational Site Number 1000014
City
Dimitrovgrad
Country
Bulgaria
Facility Name
Investigational Site Number 1000017
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Investigational Site Number 1000007
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Investigational Site Number 1000013
City
Kyustendil
Country
Bulgaria
Facility Name
Investigational Site Number 1000010
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
Investigational Site Number 1000008
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Investigational Site Number 1000002
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Investigational Site Number 1000012
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Investigational Site Number 1000003
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Investigational Site Number 1000001
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigational Site Number 1000005
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Investigational Site Number 1000006
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Investigational Site Number 1000009
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Investigational Site Number 1000016
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Facility Name
Investigational Site Number 1240001
City
Barrie
ZIP/Postal Code
L4N 7L3
Country
Canada
Facility Name
Investigational Site Number 1240002
City
Brampton
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
Investigational Site Number 1240018
City
Burlington
ZIP/Postal Code
L7M 1K9
Country
Canada
Facility Name
Investigational Site Number 1240021
City
Burlington
ZIP/Postal Code
L7R 1E2
Country
Canada
Facility Name
Investigational Site Number 1240007
City
Calgary
ZIP/Postal Code
T2H 2G4
Country
Canada
Facility Name
Investigational Site Number 1240020
City
Calgary
ZIP/Postal Code
T2V 4J2
Country
Canada
Facility Name
Investigational Site Number 1240024
City
Chicoutimi
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Investigational Site Number 1240004
City
Concord
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
Investigational Site Number 1240005
City
Etobicoke
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Investigational Site Number 1240011
City
Levis
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Investigational Site Number 1240025
City
London
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Investigational Site Number 1240028
City
London
ZIP/Postal Code
N6A 5R8
Country
Canada
Facility Name
Investigational Site Number 1240029
City
Mirabel
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Investigational Site Number 1240008
City
Montreal
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Investigational Site Number 1240031
City
Montreal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Investigational Site Number 1240014
City
Montreal
ZIP/Postal Code
H4A 2C6
Country
Canada
Facility Name
Investigational Site Number 1240023
City
Montreal
ZIP/Postal Code
H4A 3T2
Country
Canada
Facility Name
Investigational Site Number 1240017
City
Montreal
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Investigational Site Number 1240015
City
Oakville
ZIP/Postal Code
L6M 1M1
Country
Canada
Facility Name
Investigational Site Number 1240012
City
Oshawa
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Investigational Site Number 1240030
City
Ottawa
ZIP/Postal Code
K2J 0V2
Country
Canada
Facility Name
Investigational Site Number 1240027
City
Peterborough
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
Investigational Site Number 1240016
City
Pointe-Claire
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Investigational Site Number 1240010
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Investigational Site Number 1240019
City
Red Deer
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Investigational Site Number 1240006
City
Sherbrooke
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Investigational Site Number 1240022
City
Sudbury
ZIP/Postal Code
P3E 4H5
Country
Canada
Facility Name
Investigational Site Number 1240013
City
Toronto
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Investigational Site Number 1240003
City
Vancouver
ZIP/Postal Code
V5Y 3W2
Country
Canada
Facility Name
Investigational Site Number 1240009
City
Victoriaville
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Investigational Site Number 1240026
City
Victoria
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
Investigational Site Number 1520012
City
Antofagasta
ZIP/Postal Code
1270013
Country
Chile
Facility Name
Investigational Site Number 1520008
City
Concepción
ZIP/Postal Code
4070566
Country
Chile
Facility Name
Investigational Site Number 1520013
City
Santiago
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Investigational Site Number 1520002
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Investigational Site Number 1520007
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Investigational Site Number 1520011
City
Santiago
ZIP/Postal Code
7770086
Country
Chile
Facility Name
Investigational Site Number 1520010
City
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Investigational Site Number 1520001
City
Santiago
ZIP/Postal Code
8330336
Country
Chile
Facility Name
Investigational Site Number 1520003
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Investigational Site Number 1520014
City
Santiago
ZIP/Postal Code
8900132
Country
Chile
Facility Name
Investigational Site Number 1520005
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 1520006
City
Temuco
ZIP/Postal Code
4813299
Country
Chile
Facility Name
Investigational Site Number 1520004
City
Viña Del Mar
Country
Chile
Facility Name
Investigational Site Number 2080004
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigational Site Number 2080005
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Investigational Site Number 2080001
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Investigational Site Number 2080003
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Investigational Site Number 2080002
City
København Nv
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Investigational Site Number 2330002
City
Pärnu
ZIP/Postal Code
80018
Country
Estonia
Facility Name
Investigational Site Number 2330001
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site Number 2330003
City
Viljandi
ZIP/Postal Code
71024
Country
Estonia
Facility Name
Investigational Site Number 2460002
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Investigational Site Number 2460001
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Investigational Site Number 2460003
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Investigational Site Number 2460004
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Investigational Site Number 2760006
City
Berlin
ZIP/Postal Code
10437
Country
Germany
Facility Name
Investigational Site Number 2760009
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Investigational Site Number 2760004
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Investigational Site Number 2760008
City
Frankfurt Am Main
ZIP/Postal Code
60313
Country
Germany
Facility Name
Investigational Site Number 2760005
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Investigational Site Number 2760003
City
Oldenburg In Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Investigational Site Number 2760002
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Investigational Site Number 2760007
City
Rotenburg An Der Fulda
ZIP/Postal Code
36199
Country
Germany
Facility Name
Investigational Site Number 3480012
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Investigational Site Number 3480011
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Investigational Site Number 3480003
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Investigational Site Number 3480005
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Investigational Site Number 3480001
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Investigational Site Number 3480006
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 3480002
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 3480009
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Investigational Site Number 3480008
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Investigational Site Number 3480007
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Investigational Site Number 3480004
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Investigational Site Number 3560001
City
Belgaum
ZIP/Postal Code
590010
Country
India
Facility Name
Investigational Site Number 3560002
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Investigational Site Number 3560007
City
Kolkata
ZIP/Postal Code
700073
Country
India
Facility Name
Investigational Site Number 3560006
City
Lucknow
ZIP/Postal Code
226002
Country
India
Facility Name
Investigational Site Number 3560003
City
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Investigational Site Number 3560009
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Investigational Site Number 3560010
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Investigational Site Number 3560005
City
Pune
ZIP/Postal Code
411010
Country
India
Facility Name
Investigational Site Number 3560004
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Investigational Site Number 3800006
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Investigational Site Number 3800003
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Investigational Site Number 3800005
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Investigational Site Number 3800002
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Investigational Site Number 3800001
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigational Site Number 3800004
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Investigational Site Number 4100006
City
Guri-si
State/Province
Gyeonggi-Do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100007
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100005
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100002
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100009
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100001
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100011
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100003
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100010
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100008
City
Wonju
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Investigational Site Number 4280004
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Investigational Site Number 4280002
City
Liepāja
ZIP/Postal Code
LV3414
Country
Latvia
Facility Name
Investigational Site Number 4280001
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Investigational Site Number 4280003
City
Sigulda
ZIP/Postal Code
LV-2150
Country
Latvia
Facility Name
Investigational Site Number 4400001
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Facility Name
Investigational Site Number 4400002
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Investigational Site Number 4400003
City
Klaipeda
ZIP/Postal Code
92111
Country
Lithuania
Facility Name
Investigational Site Number 4400004
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Investigational Site Number 4840004
City
Actopan
ZIP/Postal Code
42500
Country
Mexico
Facility Name
Investigational Site Number 4840007
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Investigational Site Number 4840009
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Investigational Site Number 4840013
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Investigational Site Number 4840014
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Investigational Site Number 4840002
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Investigational Site Number 4840016
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Investigational Site Number 4840015
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Facility Name
Investigational Site Number 4840006
City
Guadalajara
ZIP/Postal Code
44210
Country
Mexico
Facility Name
Investigational Site Number 4840003
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Investigational Site Number 4840005
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Investigational Site Number 4840011
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Investigational Site Number 4840010
City
Monterrey
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Investigational Site Number 4840001
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 5780002
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Investigational Site Number 5780001
City
Oslo
Country
Norway
Facility Name
Investigational Site Number 5780003
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Investigational Site Number 6040007
City
Lima
ZIP/Postal Code
LIMA 01
Country
Peru
Facility Name
Investigational Site Number 6040004
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Investigational Site Number 6040003
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Investigational Site Number 6040006
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Investigational Site Number 6040001
City
Lima
Country
Peru
Facility Name
Investigational Site Number 6040005
City
Lima
Country
Peru
Facility Name
Investigational Site Number 6040002
City
Piura
ZIP/Postal Code
20000
Country
Peru
Facility Name
Investigational Site Number 6160017
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Investigational Site Number 6160018
City
Bydgoszcz
ZIP/Postal Code
80-095
Country
Poland
Facility Name
Investigational Site Number 6160015
City
Bydgoszcz
ZIP/Postal Code
85-090
Country
Poland
Facility Name
Investigational Site Number 6160016
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Investigational Site Number 6160012
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Investigational Site Number 6160005
City
Katowice
ZIP/Postal Code
40-530
Country
Poland
Facility Name
Investigational Site Number 6160006
City
Plock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Investigational Site Number 6160011
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Investigational Site Number 6160013
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Investigational Site Number 6160010
City
Szczecin
ZIP/Postal Code
70-506
Country
Poland
Facility Name
Investigational Site Number 6160007
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Investigational Site Number 6160009
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Investigational Site Number 6160014
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Investigational Site Number 6160002
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Investigational Site Number 6160004
City
Wroclaw
ZIP/Postal Code
50-315
Country
Poland
Facility Name
Investigational Site Number 6420007
City
Bacau
ZIP/Postal Code
600154
Country
Romania
Facility Name
Investigational Site Number 6420001
City
Brasov
ZIP/Postal Code
500097
Country
Romania
Facility Name
Investigational Site Number 6420011
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Investigational Site Number 6420009
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Investigational Site Number 6420012
City
Oradea
ZIP/Postal Code
410151
Country
Romania
Facility Name
Investigational Site Number 6420005
City
Oradea
ZIP/Postal Code
410159
Country
Romania
Facility Name
Investigational Site Number 6420010
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 6420008
City
Ploiesti
ZIP/Postal Code
100561
Country
Romania
Facility Name
Investigational Site Number 6420002
City
Târgu-Mureş
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 6420003
City
Târgu-Mureş
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 6430018
City
Kaliningrad
ZIP/Postal Code
236035
Country
Russian Federation
Facility Name
Investigational Site Number 6430014
City
Kazan
ZIP/Postal Code
420087
Country
Russian Federation
Facility Name
Investigational Site Number 6430001
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Investigational Site Number 6430017
City
Krasnogorsk
ZIP/Postal Code
143408
Country
Russian Federation
Facility Name
Investigational Site Number 6430004
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Investigational Site Number 6430005
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Investigational Site Number 6430002
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Investigational Site Number 6430015
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Investigational Site Number 6430009
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Investigational Site Number 6430019
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Investigational Site Number 6430006
City
Saint-Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
Investigational Site Number 6430012
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Investigational Site Number 6430003
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Investigational Site Number 6430020
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
Investigational Site Number 6430010
City
St-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Investigational Site Number 6430011
City
St-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Investigational Site Number 6430013
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Investigational Site Number 6430016
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Investigational Site Number 6880001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number 6880002
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number 6880003
City
Belgrade
ZIP/Postal Code
11050
Country
Serbia
Facility Name
Investigational Site Number 6880005
City
Belgrade
ZIP/Postal Code
11050
Country
Serbia
Facility Name
Investigational Site Number 6880004
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Investigational Site Number 6880006
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Investigational Site Number 7030007
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Investigational Site Number 7030001
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Investigational Site Number 7030004
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Investigational Site Number 7030003
City
Kralovsky Chlmec
ZIP/Postal Code
077 01
Country
Slovakia
Facility Name
Investigational Site Number 7030009
City
Moldava Nad Bodvou
ZIP/Postal Code
04525
Country
Slovakia
Facility Name
Investigational Site Number 7030010
City
Pezinok
ZIP/Postal Code
90201
Country
Slovakia
Facility Name
Investigational Site Number 7030006
City
Povazska Bystrica
ZIP/Postal Code
01701
Country
Slovakia
Facility Name
Investigational Site Number 7030005
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Investigational Site Number 7030008
City
Roznava
ZIP/Postal Code
04801
Country
Slovakia
Facility Name
Investigational Site Number 7030011
City
Sturovo
ZIP/Postal Code
943 01
Country
Slovakia
Facility Name
Investigational Site Number 7030002
City
Trebisov
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
Investigational Site Number 7030012
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Investigational Site Number 7100007
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 7100005
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number 7100006
City
Cape Town
Country
South Africa
Facility Name
Investigational Site Number 7100003
City
Johannesburg
ZIP/Postal Code
1752
Country
South Africa
Facility Name
Investigational Site Number 7100001
City
Johannesburg
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Investigational Site Number 7100002
City
Parow
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number 7100004
City
Rivonia
ZIP/Postal Code
2128
Country
South Africa
Facility Name
Investigational Site Number 7100008
City
Umhlanga Rocks Suburb
Country
South Africa
Facility Name
Investigational Site Number 7240008
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Investigational Site Number 7240002
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number 7240009
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Investigational Site Number 7240007
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Investigational Site Number 7240010
City
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Investigational Site Number 7240001
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 7240006
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Investigational Site Number 7240011
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 7240005
City
Olot
ZIP/Postal Code
17800
Country
Spain
Facility Name
Investigational Site Number 7240003
City
San Sebastián De Los Reyes
ZIP/Postal Code
28702
Country
Spain
Facility Name
Investigational Site Number 7240013
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Investigational Site Number 7240004
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Investigational Site Number 7240014
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site Number 7520006
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Investigational Site Number 7520003
City
Helsingborg
ZIP/Postal Code
252 20
Country
Sweden
Facility Name
Investigational Site Number 7520004
City
Kristianstad
ZIP/Postal Code
291 85
Country
Sweden
Facility Name
Investigational Site Number 7520002
City
Malmö
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Investigational Site Number 7520005
City
Skövde
ZIP/Postal Code
541 40
Country
Sweden
Facility Name
Investigational Site Number 7520001
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Investigational Site Number 7920005
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Investigational Site Number 7920010
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Investigational Site Number 7920012
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Investigational Site Number 7920015
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Investigational Site Number 7920002
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Investigational Site Number 7920013
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Facility Name
Investigational Site Number 7920001
City
Istanbul
ZIP/Postal Code
34393
Country
Turkey
Facility Name
Investigational Site Number 7920006
City
Istanbul
ZIP/Postal Code
34843
Country
Turkey
Facility Name
Investigational Site Number 7920011
City
Izmit
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Investigational Site Number 7920014
City
Kutahya
ZIP/Postal Code
43040
Country
Turkey
Facility Name
Investigational Site Number 7920007
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Investigational Site Number 7920009
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Investigational Site Number 8040006
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Investigational Site Number 8040009
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Investigational Site Number 8040001
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number 8040003
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Investigational Site Number 8040002
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Investigational Site Number 8040007
City
Kiev
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Investigational Site Number 8040008
City
Kyiv
ZIP/Postal Code
01004
Country
Ukraine
Facility Name
Investigational Site Number 8040004
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Investigational Site Number 8040005
City
Vinnytsya
ZIP/Postal Code
21001
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.
Citations:
PubMed Identifier
34215025
Citation
Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K; AMPLITUDE-O Trial Investigators. Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28.
Results Reference
result
PubMed Identifier
34775781
Citation
Lam CSP, Ramasundarahettige C, Branch KRH, Sattar N, Rosenstock J, Pratley R, Del Prato S, Lopes RD, Niemoeller E, Khurmi NS, Baek S, Gerstein HC. Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial. Circulation. 2022 Feb 22;145(8):565-574. doi: 10.1161/CIRCULATIONAHA.121.057934. Epub 2021 Nov 14. Erratum In: Circulation. 2023 Jun 6;147(23):e720.
Results Reference
derived
PubMed Identifier
33026143
Citation
Gerstein HC, Branch K, Heenan L, Del Prato S, Khurmi NS, Lam CSP, Pratley R, Rosenstock J, Sattar N. Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist. Diabetes Obes Metab. 2021 Feb;23(2):318-323. doi: 10.1111/dom.14223. Epub 2020 Oct 22.
Results Reference
derived

Learn more about this trial

Effect of Efpeglenatide on Cardiovascular Outcomes

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