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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (EDITION I)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HOE901-U300 (new formulation of insulin glargine)
Lantus (insulin glargine)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion criteria :

  • Participants with type 2 diabetes mellitus

  • Substudy inclusion criteria:

    • Completion of the 6-month study period in main study (Visit 10)
    • Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

  • Age less than (<) 18 years
  • HbA1c <7.0% or greater than (>) 10% at screening
  • Diabetes other than type 2 diabetes mellitus
  • Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
  • Any contraindication to use of insulin glargine as defined in the national product label
  • Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
  • Use of an insulin pump in the last 6 months before screening visit
  • Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
  • History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study period

  • Substudy exclusion criteria:

    • Participant not willing to use the adaptable injection intervals on at least two days per week

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

Sites / Locations

  • Investigational Site Number 840156
  • Investigational Site Number 840102
  • Investigational Site Number 840071
  • Investigational Site Number 840121
  • Investigational Site Number 840070
  • Investigational Site Number 840016
  • Investigational Site Number 840015
  • Investigational Site Number 840124
  • Investigational Site Number 840032
  • Investigational Site Number 840076
  • Investigational Site Number 840133
  • Investigational Site Number 840062
  • Investigational Site Number 840057
  • Investigational Site Number 840059
  • Investigational Site Number 840004
  • Investigational Site Number 840099
  • Investigational Site Number 840107
  • Investigational Site Number 840005
  • Investigational Site Number 840013
  • Investigational Site Number 840002
  • Investigational Site Number 840114
  • Investigational Site Number 840136
  • Investigational Site Number 840092
  • Investigational Site Number 840049
  • Investigational Site Number 840050
  • Investigational Site Number 840086
  • Investigational Site Number 840011
  • Investigational Site Number 840009
  • Investigational Site Number 840023
  • Investigational Site Number 840012
  • Investigational Site Number 840148
  • Investigational Site Number 840055
  • Investigational Site Number 840052
  • Investigational Site Number 840117
  • Investigational Site Number 840020
  • Investigational Site Number 840019
  • Investigational Site Number 840078
  • Investigational Site Number 840089
  • Investigational Site Number 840097
  • Investigational Site Number 840098
  • Investigational Site Number 840100
  • Investigational Site Number 840127
  • Investigational Site Number 840116
  • Investigational Site Number 840003
  • Investigational Site Number 840080
  • Investigational Site Number 840042
  • Investigational Site Number 840036
  • Investigational Site Number 840155
  • Investigational Site Number 840034
  • Investigational Site Number 840065
  • Investigational Site Number 840066
  • Investigational Site Number 840103
  • Investigational Site Number 840126
  • Investigational Site Number 840022
  • Investigational Site Number 840143
  • Investigational Site Number 840068
  • Investigational Site Number 840085
  • Investigational Site Number 840053
  • Investigational Site Number 840090
  • Investigational Site Number 840091
  • Investigational Site Number 840058
  • Investigational Site Number 840043
  • Investigational Site Number 840152
  • Investigational Site Number 840146
  • Investigational Site Number 840145
  • Investigational Site Number 840045
  • Investigational Site Number 840067
  • Investigational Site Number 840008
  • Investigational Site Number 840106
  • Investigational Site Number 840123
  • Investigational Site Number 840119
  • Investigational Site Number 840122
  • Investigational Site Number 840083
  • Investigational Site Number 840084
  • Investigational Site Number 840007
  • Investigational Site Number 840079
  • Investigational Site Number 840048
  • Investigational Site Number 840039
  • Investigational Site Number 840159
  • Investigational Site Number 840021
  • Investigational Site Number 840129
  • Investigational Site Number 840081
  • Investigational Site Number 840001
  • Investigational Site Number 840047
  • Investigational Site Number 840082
  • Investigational Site Number 840120
  • Investigational Site Number 840010
  • Investigational Site Number 840060
  • Investigational Site Number 840035
  • Investigational Site Number 840074
  • Investigational Site Number 840112
  • Investigational Site Number 840041
  • Investigational Site Number 840104
  • Investigational Site Number 840075
  • Investigational Site Number 840018
  • Investigational Site Number 124024
  • Investigational Site Number 124025
  • Investigational Site Number 124023
  • Investigational Site Number 124020
  • Investigational Site Number 124019
  • Investigational Site Number 124018
  • Investigational Site Number 124021
  • Investigational Site Number 124014
  • Investigational Site Number 124006
  • Investigational Site Number 124009
  • Investigational Site Number 124008
  • Investigational Site Number 124015
  • Investigational Site Number 124004
  • Investigational Site Number 124005
  • Investigational Site Number 124026
  • Investigational Site Number 124002
  • Investigational Site Number 124007
  • Investigational Site Number 124001
  • Investigational Site Number 124011
  • Investigational Site Number 124010
  • Investigational Site Number 124017
  • Investigational Site Number 124022
  • Investigational Site Number 203006
  • Investigational Site Number 203001
  • Investigational Site Number 203002
  • Investigational Site Number 203009
  • Investigational Site Number 203003
  • Investigational Site Number 203007
  • Investigational Site Number 203004
  • Investigational Site Number 203010
  • Investigational Site Number 203008
  • Investigational Site Number 203005
  • Investigational Site Number 233002
  • Investigational Site Number 233004
  • Investigational Site Number 233006
  • Investigational Site Number 233003
  • Investigational Site Number 233001
  • Investigational Site Number 233005
  • Investigational Site Number 246001
  • Investigational Site Number 246005
  • Investigational Site Number 246002
  • Investigational Site Number 250004
  • Investigational Site Number 250002
  • Investigational Site Number 276006
  • Investigational Site Number 276002
  • Investigational Site Number 276003
  • Investigational Site Number 348010
  • Investigational Site Number 348004
  • Investigational Site Number 348015
  • Investigational Site Number 348013
  • Investigational Site Number 348017
  • Investigational Site Number 348009
  • Investigational Site Number 348002
  • Investigational Site Number 348005
  • Investigational Site Number 348008
  • Investigational Site Number 348018
  • Investigational Site Number 348014
  • Investigational Site Number 348012
  • Investigational Site Number 348007
  • Investigational Site Number 348003
  • Investigational Site Number 348006
  • Investigational Site Number 348011
  • Investigational Site Number 348001
  • Investigational Site Number 428006
  • Investigational Site Number 428005
  • Investigational Site Number 428002
  • Investigational Site Number 428001
  • Investigational Site Number 428004
  • Investigational Site Number 428003
  • Investigational Site Number 484007
  • Investigational Site Number 484001
  • Investigational Site Number 484006
  • Investigational Site Number 484003
  • Investigational Site Number 484004
  • Investigational Site Number 528009
  • Investigational Site Number 528004
  • Investigational Site Number 528007
  • Investigational Site Number 528005
  • Investigational Site Number 528001
  • Investigational Site Number 528008
  • Investigational Site Number 528006
  • Investigational Site Number 528002
  • Investigational Site Number 642001
  • Investigational Site Number 642005
  • Investigational Site Number 642006
  • Investigational Site Number 642002
  • Investigational Site Number 642004
  • Investigational Site Number 642008
  • Investigational Site Number 642003
  • Investigational Site Number 642009
  • Investigational Site Number 642007
  • Investigational Site Number 710005
  • Investigational Site Number 710003
  • Investigational Site Number 710006
  • Investigational Site Number 710002
  • Investigational Site Number 710001
  • Investigational Site Number 710008
  • Investigational Site Number 710004

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOE901-U300

Lantus

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Month 6 Endpoint

Secondary Outcome Measures

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).

Full Information

First Posted
December 16, 2011
Last Updated
March 15, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01499082
Brief Title
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Acronym
EDITION I
Official Title
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Primary Objective: To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus Secondary Objectives: To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia
Detailed Description
The maximum study duration was up to approximately 58 weeks per participant, consisting of: up to 2 week screening period 6-month comparative efficacy and safety treatment period 6-month comparative safety extension period 4-week safety follow-up period in a subset of participants a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
807 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOE901-U300
Arm Type
Experimental
Arm Title
Lantus
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HOE901-U300 (new formulation of insulin glargine)
Intervention Description
HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.
Intervention Type
Drug
Intervention Name(s)
Lantus (insulin glargine)
Other Intervention Name(s)
Lantus
Intervention Description
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Month 6 Endpoint
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Description
Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).
Time Frame
Week 9 Up to Month 6
Title
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Description
Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.
Time Frame
Baseline, Month 6
Title
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Description
Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Time Frame
Baseline, Month 6
Title
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Time Frame
Month 6
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Time Frame
Baseline, Month 6
Title
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Time Frame
Month 6
Title
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Description
Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.
Time Frame
Baseline, Month 6
Title
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Time Frame
Baseline, Month 6
Title
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
Description
DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
Time Frame
Baseline, Month 6
Title
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
Description
Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).
Time Frame
Up to Month 12
Other Pre-specified Outcome Measures:
Title
Change in HbA1c From Month 6 to Month 9
Description
Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.
Time Frame
Month 6 Up to Month 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Participants with type 2 diabetes mellitus Substudy inclusion criteria: Completion of the 6-month study period in main study (Visit 10) Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6) Exclusion criteria: Age less than (<) 18 years HbA1c <7.0% or greater than (>) 10% at screening Diabetes other than type 2 diabetes mellitus Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose Any contraindication to use of insulin glargine as defined in the national product label Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit Use of an insulin pump in the last 6 months before screening visit Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period Pregnant or breast-feeding women or women who intend to become pregnant during the study period Substudy exclusion criteria: Participant not willing to use the adaptable injection intervals on at least two days per week The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840156
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigational Site Number 840102
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Investigational Site Number 840071
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Investigational Site Number 840121
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Investigational Site Number 840070
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Investigational Site Number 840016
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Investigational Site Number 840015
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840124
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840032
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
Investigational Site Number 840076
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Investigational Site Number 840133
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Investigational Site Number 840062
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigational Site Number 840057
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Investigational Site Number 840059
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840004
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840099
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigational Site Number 840107
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigational Site Number 840005
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Investigational Site Number 840013
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Investigational Site Number 840002
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Investigational Site Number 840114
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Investigational Site Number 840136
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Investigational Site Number 840092
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Investigational Site Number 840049
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Investigational Site Number 840050
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigational Site Number 840086
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Investigational Site Number 840011
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 840009
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Investigational Site Number 840023
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840012
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Investigational Site Number 840148
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840055
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Investigational Site Number 840052
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840117
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Investigational Site Number 840020
City
McHenry
State/Province
Illinois
ZIP/Postal Code
60050
Country
United States
Facility Name
Investigational Site Number 840019
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Investigational Site Number 840078
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840089
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840097
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840098
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840100
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840127
City
Vincennes
State/Province
Indiana
ZIP/Postal Code
47591
Country
United States
Facility Name
Investigational Site Number 840116
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Investigational Site Number 840003
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Facility Name
Investigational Site Number 840080
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Investigational Site Number 840042
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Investigational Site Number 840036
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840155
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840034
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840065
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Investigational Site Number 840066
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Investigational Site Number 840103
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Investigational Site Number 840126
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Investigational Site Number 840022
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Investigational Site Number 840143
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Investigational Site Number 840068
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55122
Country
United States
Facility Name
Investigational Site Number 840085
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Investigational Site Number 840053
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Investigational Site Number 840090
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Investigational Site Number 840091
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Investigational Site Number 840058
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigational Site Number 840043
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08274
Country
United States
Facility Name
Investigational Site Number 840152
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08721
Country
United States
Facility Name
Investigational Site Number 840146
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Investigational Site Number 840145
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Investigational Site Number 840045
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Investigational Site Number 840067
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Investigational Site Number 840008
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Investigational Site Number 840106
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site Number 840123
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Investigational Site Number 840119
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Investigational Site Number 840122
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Investigational Site Number 840083
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigational Site Number 840084
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Investigational Site Number 840007
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Investigational Site Number 840079
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigational Site Number 840048
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site Number 840039
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigational Site Number 840159
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Investigational Site Number 840021
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigational Site Number 840129
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigational Site Number 840081
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Investigational Site Number 840001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840047
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840082
City
Houston
State/Province
Texas
ZIP/Postal Code
77096
Country
United States
Facility Name
Investigational Site Number 840120
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Investigational Site Number 840010
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Investigational Site Number 840060
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Investigational Site Number 840035
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Investigational Site Number 840074
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Investigational Site Number 840112
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Investigational Site Number 840041
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Investigational Site Number 840104
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Investigational Site Number 840075
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
Investigational Site Number 840018
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
Investigational Site Number 124024
City
Beamsville
ZIP/Postal Code
L0R 1B0
Country
Canada
Facility Name
Investigational Site Number 124025
City
Burlington
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Investigational Site Number 124023
City
Calgary
ZIP/Postal Code
T2H 2G4
Country
Canada
Facility Name
Investigational Site Number 124020
City
Calgary
ZIP/Postal Code
T2N 4L7
Country
Canada
Facility Name
Investigational Site Number 124019
City
Chatham
ZIP/Postal Code
N7L 1C1
Country
Canada
Facility Name
Investigational Site Number 124018
City
Coquitlam
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Investigational Site Number 124021
City
Hamilton
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Investigational Site Number 124014
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Investigational Site Number 124006
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Investigational Site Number 124009
City
London
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Investigational Site Number 124008
City
Mississauga
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Investigational Site Number 124015
City
Montreal
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Investigational Site Number 124004
City
Montreal
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Investigational Site Number 124005
City
Oshawa
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
Investigational Site Number 124026
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Investigational Site Number 124002
City
Red Deer
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Investigational Site Number 124007
City
Thornhill
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Investigational Site Number 124001
City
Toronto
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Investigational Site Number 124011
City
Toronto
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Investigational Site Number 124010
City
Victoria
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
Investigational Site Number 124017
City
Ville St-Laurent
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Investigational Site Number 124022
City
Winnipeg
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Investigational Site Number 203006
City
Beroun
ZIP/Postal Code
26601
Country
Czechia
Facility Name
Investigational Site Number 203001
City
Breclav
ZIP/Postal Code
690 02
Country
Czechia
Facility Name
Investigational Site Number 203002
City
Hodonin
ZIP/Postal Code
69501
Country
Czechia
Facility Name
Investigational Site Number 203009
City
Holesov
ZIP/Postal Code
76901
Country
Czechia
Facility Name
Investigational Site Number 203003
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number 203007
City
Hranice
ZIP/Postal Code
75301
Country
Czechia
Facility Name
Investigational Site Number 203004
City
Krnov
ZIP/Postal Code
79401
Country
Czechia
Facility Name
Investigational Site Number 203010
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Investigational Site Number 203008
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number 203005
City
Prostejov
ZIP/Postal Code
79601
Country
Czechia
Facility Name
Investigational Site Number 233002
City
Pärnu
ZIP/Postal Code
80018
Country
Estonia
Facility Name
Investigational Site Number 233004
City
Tallinn
ZIP/Postal Code
11313
Country
Estonia
Facility Name
Investigational Site Number 233006
City
Tallinn
ZIP/Postal Code
11913
Country
Estonia
Facility Name
Investigational Site Number 233003
City
Tallinn
ZIP/Postal Code
13415
Country
Estonia
Facility Name
Investigational Site Number 233001
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site Number 233005
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
Investigational Site Number 246001
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Investigational Site Number 246005
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Investigational Site Number 246002
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Investigational Site Number 250004
City
La Rochelle Cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Investigational Site Number 250002
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Investigational Site Number 276006
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Investigational Site Number 276002
City
Riesa
ZIP/Postal Code
01587
Country
Germany
Facility Name
Investigational Site Number 276003
City
Schwabenheim
ZIP/Postal Code
55270
Country
Germany
Facility Name
Investigational Site Number 348010
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Investigational Site Number 348015
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Investigational Site Number 348013
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Investigational Site Number 348017
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 348009
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Investigational Site Number 348002
City
Budapest
Country
Hungary
Facility Name
Investigational Site Number 348005
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Investigational Site Number 348008
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Investigational Site Number 348018
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Investigational Site Number 348014
City
Makó
ZIP/Postal Code
6900
Country
Hungary
Facility Name
Investigational Site Number 348012
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Investigational Site Number 348007
City
Nyiregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Investigational Site Number 348006
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Investigational Site Number 348011
City
Sátorlaljaújhely
ZIP/Postal Code
3980
Country
Hungary
Facility Name
Investigational Site Number 348001
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Investigational Site Number 428006
City
Jekabpils
ZIP/Postal Code
LV-5201
Country
Latvia
Facility Name
Investigational Site Number 428005
City
Ogre
ZIP/Postal Code
LV-5001
Country
Latvia
Facility Name
Investigational Site Number 428002
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number 428001
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Investigational Site Number 428004
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
Facility Name
Investigational Site Number 428003
City
Sigulda
ZIP/Postal Code
LV-2150
Country
Latvia
Facility Name
Investigational Site Number 484007
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Investigational Site Number 484006
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 484004
City
Pachuca
ZIP/Postal Code
42060
Country
Mexico
Facility Name
Investigational Site Number 528009
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Investigational Site Number 528004
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
Investigational Site Number 528007
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Investigational Site Number 528005
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Investigational Site Number 528001
City
Hoorn
ZIP/Postal Code
1064NP
Country
Netherlands
Facility Name
Investigational Site Number 528008
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Investigational Site Number 528006
City
Utrecht
ZIP/Postal Code
3563 AZ
Country
Netherlands
Facility Name
Investigational Site Number 528002
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Investigational Site Number 642001
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Facility Name
Investigational Site Number 642005
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Investigational Site Number 642006
City
Bucuresti
ZIP/Postal Code
700164
Country
Romania
Facility Name
Investigational Site Number 642002
City
Cluj Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Investigational Site Number 642004
City
Iasi
ZIP/Postal Code
700547
Country
Romania
Facility Name
Investigational Site Number 642008
City
Iasi
ZIP/Postal Code
700613
Country
Romania
Facility Name
Investigational Site Number 642003
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642009
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 642007
City
Timisoara
ZIP/Postal Code
300133
Country
Romania
Facility Name
Investigational Site Number 710005
City
Alberton
ZIP/Postal Code
1450
Country
South Africa
Facility Name
Investigational Site Number 710003
City
Johannesburg
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Investigational Site Number 710006
City
Lenasia
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Investigational Site Number 710002
City
Observatory
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Investigational Site Number 710001
City
Paarl
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number 710008
City
Pretoria
ZIP/Postal Code
0167
Country
South Africa
Facility Name
Investigational Site Number 710004
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa

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
Citations:
PubMed Identifier
25078900
Citation
Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014 Oct;37(10):2755-62. doi: 10.2337/dc14-0991. Epub 2014 Jul 30.
Results Reference
result
PubMed Identifier
30366067
Citation
Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.
Results Reference
derived
PubMed Identifier
29649539
Citation
Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.
Results Reference
derived

Learn more about this trial

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

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