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A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
HOE901-U300 (Insulin Glargine 300 U/ml)
Lantus (Insulin Glargine 100 U/ml)
Mandated back ground therapy
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Adult participants (male and female) with type 1 diabetes mellitus (T1DM).
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years or >70 years.
  • Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.
  • Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.
  • Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening.
  • Participants who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.
  • Participants received less than 1 year treatment with basal plus mealtime insulin.
  • Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.
  • Required >80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.
  • Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.
  • Used human regular insulin as mealtime insulin within 30 days prior to screening.
  • Used an insulin pump during the last 6 months before screening.
  • History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.
  • Pregnant or breast-feeding women or planned pregnancy during the duration of the study.
  • Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening.
  • Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.
  • Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.

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

Sites / Locations

  • Investigational Site Number 840-151
  • Investigational Site Number 840-071
  • Investigational Site Number 840-149
  • Investigational Site Number 840-004
  • Investigational Site Number 840-110
  • Investigational Site Number 840-124
  • Investigational Site Number 840-030
  • Investigational Site Number 840-044
  • Investigational Site Number 840-022
  • Investigational Site Number 840-129
  • Investigational Site Number 840-024
  • Investigational Site Number 840-069
  • Investigational Site Number 840-090
  • Investigational Site Number 840-132
  • Investigational Site Number 840-130
  • Investigational Site Number 840-055
  • Investigational Site Number 840-028
  • Investigational Site Number 840-063
  • Investigational Site Number 840-138
  • Investigational Site Number 840-016
  • Investigational Site Number 840-039
  • Investigational Site Number 840-021
  • Investigational Site Number 840-070
  • Investigational Site Number 840-046
  • Investigational Site Number 840-072
  • Investigational Site Number 840-133
  • Investigational Site Number 840-137
  • Investigational Site Number 840-049
  • Investigational Site Number 840-076
  • Investigational Site Number 840-023
  • Investigational Site Number 840-053
  • Investigational Site Number 840-112
  • Investigational Site Number 840-018
  • Investigational Site Number 840-047
  • Investigational Site Number 840-114
  • Investigational Site Number 840-036
  • Investigational Site Number 840-001
  • Investigational Site Number 840-064
  • Investigational Site Number 840-012
  • Investigational Site Number 840-008
  • Investigational Site Number 840-014
  • Investigational Site Number 840-060
  • Investigational Site Number 840-125
  • Investigational Site Number 840-011
  • Investigational Site Number 840-134
  • Investigational Site Number 840-002
  • Investigational Site Number 840-073
  • Investigational Site Number 840-062
  • Investigational Site Number 840-042
  • Investigational Site Number 840-009
  • Investigational Site Number 840-032
  • Investigational Site Number 840-054
  • Investigational Site Number 840-006
  • Investigational Site Number 840-157
  • Investigational Site Number 840-122
  • Investigational Site Number 840-037
  • Investigational Site Number 840-067
  • Investigational Site Number 840-094
  • Investigational Site Number 840-033
  • Investigational Site Number 840-142
  • Investigational Site Number 840-040
  • Investigational Site Number 840-017
  • Investigational Site Number 840-102
  • Investigational Site Number 840-108
  • Investigational Site Number 840-109
  • Investigational Site Number 840-045
  • Investigational Site Number 840-010
  • Investigational Site Number 840-080
  • Investigational Site Number 840-051
  • Investigational Site Number 840-123
  • Investigational Site Number 840-104
  • Investigational Site Number 840-079
  • Investigational Site Number 840-162
  • Investigational Site Number 840-096
  • Investigational Site Number 840-058
  • Investigational Site Number 840-003
  • Investigational Site Number 840-019
  • Investigational Site Number 840-075
  • Investigational Site Number 840-005
  • Investigational Site Number 840-013
  • Investigational Site Number 840-153
  • Investigational Site Number 840-026
  • Investigational Site Number 840-081
  • Investigational Site Number 840-160
  • Investigational Site Number 840-156
  • Investigational Site Number 840-152
  • Investigational Site Number 840-031
  • Investigational Site Number 840-140
  • Investigational Site Number 840-029
  • Investigational Site Number 840-048
  • Investigational Site Number 840-150
  • Investigational Site Number 840-083
  • Investigational Site Number 840-101
  • Investigational Site Number 840-097
  • Investigational Site Number 840-143
  • Investigational Site Number 840-056
  • Investigational Site Number 840-015
  • Investigational Site Number 840-074
  • Investigational Site Number 840-139
  • Investigational Site Number 840-111

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOE901-U300

Lantus

Arm Description

HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia.

Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.

Outcomes

Primary Outcome Measures

Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).

Secondary Outcome Measures

Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia
Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).
Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year
Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.
Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16
Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).
Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection
Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).
Coefficient of Variation (CV%) in Mean CGM Glucose
CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.

Full Information

First Posted
February 18, 2016
Last Updated
March 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02688933
Brief Title
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Official Title
A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 5, 2016 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus. Secondary Objective: To demonstrate that treatment with HOE901-U300 compared to Lantus provides: Lower incidence rate of nocturnal symptomatic hypoglycemia; Better glucose control coverage during the last hours of CGM before next basal-insulin dosing; Less variability in CGM profile.
Detailed Description
The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
638 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOE901-U300
Arm Type
Experimental
Arm Description
HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia.
Arm Title
Lantus
Arm Type
Active Comparator
Arm Description
Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.
Intervention Type
Drug
Intervention Name(s)
HOE901-U300 (Insulin Glargine 300 U/ml)
Other Intervention Name(s)
Toujeo
Intervention Description
Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.
Intervention Type
Drug
Intervention Name(s)
Lantus (Insulin Glargine 100 U/ml)
Other Intervention Name(s)
HOE901-U100
Intervention Description
Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.
Intervention Type
Drug
Intervention Name(s)
Mandated back ground therapy
Intervention Description
Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).
Primary Outcome Measure Information:
Title
Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM
Description
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).
Time Frame
During Week 15 and/or 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia
Description
Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).
Time Frame
Baseline up to Week 16
Title
Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year
Description
Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.
Time Frame
Baseline up to Week 16
Title
Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16
Description
Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).
Time Frame
Baseline, during Week 15 and/or Week 16
Title
Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection
Description
Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).
Time Frame
During Week 15 and/or Week 16
Title
Coefficient of Variation (CV%) in Mean CGM Glucose
Description
CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.
Time Frame
During Week 15 and/or Week 16
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Daily Insulin Dose at Week 16
Description
Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Adult participants (male and female) with type 1 diabetes mellitus (T1DM). Signed written informed consent. Exclusion criteria: Age <18 years or >70 years. Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1. Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1. Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening. Participants who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening. Participants received less than 1 year treatment with basal plus mealtime insulin. Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening. Required >80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening. Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening. Used human regular insulin as mealtime insulin within 30 days prior to screening. Used an insulin pump during the last 6 months before screening. History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period. Pregnant or breast-feeding women or planned pregnancy during the duration of the study. Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening. Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening. Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening. The above information is not intended to contain all considerations relevant to a participants'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 840-151
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840-071
City
Concord
State/Province
California
ZIP/Postal Code
94520-2270
Country
United States
Facility Name
Investigational Site Number 840-149
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Investigational Site Number 840-004
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site Number 840-110
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigational Site Number 840-124
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840-030
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840-044
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Investigational Site Number 840-022
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Investigational Site Number 840-129
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Investigational Site Number 840-024
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Investigational Site Number 840-069
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States
Facility Name
Investigational Site Number 840-090
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Investigational Site Number 840-132
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Investigational Site Number 840-130
City
San Jose
State/Province
California
ZIP/Postal Code
95148
Country
United States
Facility Name
Investigational Site Number 840-055
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Investigational Site Number 840-028
City
Santa Barbara
State/Province
California
Country
United States
Facility Name
Investigational Site Number 840-063
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Investigational Site Number 840-138
City
Tustin
State/Province
California
ZIP/Postal Code
92780-6953
Country
United States
Facility Name
Investigational Site Number 840-016
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Investigational Site Number 840-039
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Investigational Site Number 840-021
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Investigational Site Number 840-070
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number 840-046
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Investigational Site Number 840-072
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Facility Name
Investigational Site Number 840-133
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Investigational Site Number 840-137
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Investigational Site Number 840-049
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Investigational Site Number 840-076
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigational Site Number 840-023
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840-053
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Investigational Site Number 840-112
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Investigational Site Number 840-018
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840-047
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigational Site Number 840-114
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Investigational Site Number 840-036
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Investigational Site Number 840-001
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Investigational Site Number 840-064
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigational Site Number 840-012
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Investigational Site Number 840-008
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigational Site Number 840-014
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Investigational Site Number 840-060
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840-125
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Investigational Site Number 840-011
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number 840-134
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Investigational Site Number 840-002
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Investigational Site Number 840-073
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Investigational Site Number 840-062
City
Covington
State/Province
Kentucky
ZIP/Postal Code
41011
Country
United States
Facility Name
Investigational Site Number 840-042
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Investigational Site Number 840-009
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigational Site Number 840-032
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Investigational Site Number 840-054
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Investigational Site Number 840-006
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840-157
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Investigational Site Number 840-122
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Investigational Site Number 840-037
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Investigational Site Number 840-067
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Investigational Site Number 840-094
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Investigational Site Number 840-033
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Investigational Site Number 840-142
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Investigational Site Number 840-040
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Investigational Site Number 840-017
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigational Site Number 840-102
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Investigational Site Number 840-108
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Investigational Site Number 840-109
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301-3914
Country
United States
Facility Name
Investigational Site Number 840-045
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigational Site Number 840-010
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Investigational Site Number 840-080
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Investigational Site Number 840-051
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Investigational Site Number 840-123
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Investigational Site Number 840-104
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Investigational Site Number 840-079
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Investigational Site Number 840-162
City
Bend
State/Province
Oregon
ZIP/Postal Code
97702
Country
United States
Facility Name
Investigational Site Number 840-096
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Investigational Site Number 840-058
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Investigational Site Number 840-003
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840-019
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840-075
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Investigational Site Number 840-005
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840-013
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840-153
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Investigational Site Number 840-026
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Investigational Site Number 840-081
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Investigational Site Number 840-160
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Investigational Site Number 840-156
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Investigational Site Number 840-152
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Investigational Site Number 840-031
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Investigational Site Number 840-140
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Investigational Site Number 840-029
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Investigational Site Number 840-048
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Investigational Site Number 840-150
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Investigational Site Number 840-083
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Investigational Site Number 840-101
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Investigational Site Number 840-097
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Investigational Site Number 840-143
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Investigational Site Number 840-056
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Investigational Site Number 840-015
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Investigational Site Number 840-074
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Investigational Site Number 840-139
City
Bridgeport
State/Province
West Virginia
ZIP/Postal Code
26330
Country
United States
Facility Name
Investigational Site Number 840-111
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

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