search
Back to results

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
semaglutide
semaglutide
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Semaglutide 0.5 mg

Semaglutide 1.0 mg

Semaglutide placebo 0.5 mg

Semaglutide placebo 1.0 mg

Arm Description

Outcomes

Primary Outcome Measures

Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.

Secondary Outcome Measures

Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight
Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio
Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).
Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events
Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Incidence During the Trial in Other Treatment Outcomes: Adverse Events
Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies
The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)
Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)
Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).

Full Information

First Posted
October 29, 2012
Last Updated
June 20, 2019
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01720446
Brief Title
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
Acronym
SUSTAIN™ 6
Official Title
A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2013 (Actual)
Primary Completion Date
March 15, 2016 (Actual)
Study Completion Date
March 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 0.5 mg
Arm Type
Experimental
Arm Title
Semaglutide 1.0 mg
Arm Type
Experimental
Arm Title
Semaglutide placebo 0.5 mg
Arm Type
Placebo Comparator
Arm Title
Semaglutide placebo 1.0 mg
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Primary Outcome Measure Information:
Title
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Description
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Time Frame
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary Outcome Measure Information:
Title
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
Description
Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)
Time Frame
Time from randomisation up to end of follow-up (scheduled at week 109)
Title
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Description
Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).
Time Frame
Time from randomisation up to end of follow-up (scheduled at week 109)
Title
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
Description
Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
Time Frame
Time from randomisation up to end of follow-up (scheduled at week 109)
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
Description
Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
Description
Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight
Description
Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
Description
Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio
Description
Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
Description
Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).
Time Frame
Week 0, up to week 104
Title
Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events
Description
Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time Frame
Week 0 - 109
Title
Incidence During the Trial in Other Treatment Outcomes: Adverse Events
Description
Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
Time Frame
Weeks 0-109
Title
Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies
Description
The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.
Time Frame
Weeks 0-109
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Description
Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)
Description
Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
Time Frame
Week 0, up to week 104
Title
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)
Description
Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).
Time Frame
Week 0, up to week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205-4731
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017-4006
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32724
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3020
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mine Hill
State/Province
New Jersey
ZIP/Postal Code
07803
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-8050
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Whiteville
State/Province
North Carolina
ZIP/Postal Code
28472
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-6815
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009-1957
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75061-2210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228-3419
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403-7205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601-3834
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Annaba
ZIP/Postal Code
23000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Setif
ZIP/Postal Code
19000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Tizi Ouzou
ZIP/Postal Code
15000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Morón
ZIP/Postal Code
B1708IFF
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Ipswich
State/Province
Queensland
ZIP/Postal Code
4305
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Oaklands Park
State/Province
South Australia
ZIP/Postal Code
5046
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Belém
State/Province
Para
ZIP/Postal Code
66073-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13059-740
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04038-002
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1324
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4J2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Cornwall
State/Province
Ontario
ZIP/Postal Code
K6H 4M4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45219
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saint Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Delhi
State/Province
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700032
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110095
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
ZIP/Postal Code
411011
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Olbia
ZIP/Postal Code
07026
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Primo Piano Palazzina Ambulato
ZIP/Postal Code
40133
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Kota Samarahan
ZIP/Postal Code
94300
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Serdang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Mexico City
State/Province
México, D.F.
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Mexico City
State/Province
México, D.F.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
México D.F.
State/Province
México, D.F.
ZIP/Postal Code
11550
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-445
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420043
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410031
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04001
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Antequera
ZIP/Postal Code
29200
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sanlúcar De Barrameda - Cádiz-
ZIP/Postal Code
15540
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Vic (Barcelona)
ZIP/Postal Code
08500
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Chiayi City
ZIP/Postal Code
600
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Tainan city
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Canakkale
ZIP/Postal Code
17020
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS25 1AN
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30851070
Citation
Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.
Results Reference
background
PubMed Identifier
27633186
Citation
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.
Results Reference
result
PubMed Identifier
29178519
Citation
Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simo R, Helmark IC, Wijayasinghe N, Larsen M. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018 Apr;20(4):889-897. doi: 10.1111/dom.13172. Epub 2018 Jan 8.
Results Reference
result
PubMed Identifier
29907893
Citation
Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
Results Reference
result
PubMed Identifier
30615985
Citation
Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
Results Reference
result
PubMed Identifier
31167654
Citation
Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S, Gondolf T, Hansen T, Holst I, Lingvay I. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019 Jun 6;18(1):73. doi: 10.1186/s12933-019-0871-8.
Results Reference
result
PubMed Identifier
35582947
Citation
Strain WD, Frenkel O, James MA, Leiter LA, Rasmussen S, Rothwell PM, Sejersten Ripa M, Truelsen TC, Husain M. Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6. Stroke. 2022 Sep;53(9):2749-2757. doi: 10.1161/STROKEAHA.121.037775. Epub 2022 May 18.
Results Reference
derived
PubMed Identifier
35484580
Citation
Husain M, Consoli A, De Remigis A, Pettersson Meyer AS, Rasmussen S, Bain S. Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6. Cardiovasc Diabetol. 2022 Apr 28;21(1):64. doi: 10.1186/s12933-022-01489-6.
Results Reference
derived
PubMed Identifier
35332654
Citation
Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11.
Results Reference
derived
PubMed Identifier
33606902
Citation
Verma S, Fainberg U, Husain M, Rasmussen S, Ryden L, Ripa MS, Buse JB. Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide. Diabetes Obes Metab. 2021 Jul;23(7):1677-1680. doi: 10.1111/dom.14360. Epub 2021 Mar 18.
Results Reference
derived
PubMed Identifier
32998732
Citation
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
Results Reference
derived
PubMed Identifier
32744418
Citation
Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4.
Results Reference
derived
PubMed Identifier
32643857
Citation
Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12.
Results Reference
derived
PubMed Identifier
32372454
Citation
Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3.
Results Reference
derived
PubMed Identifier
32227613
Citation
Jodar E, Michelsen M, Polonsky W, Rea R, Sandberg A, Vilsboll T, Warren M, Harring S, Ziegler U, Bain S. Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6). Diabetes Obes Metab. 2020 Aug;22(8):1339-1347. doi: 10.1111/dom.14039. Epub 2020 Apr 27.
Results Reference
derived
PubMed Identifier
31903692
Citation
Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.
Results Reference
derived
PubMed Identifier
31769496
Citation
DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.
Results Reference
derived
PubMed Identifier
29693361
Citation
Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

We'll reach out to this number within 24 hrs