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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

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 :

  • Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
  • Signed written informed consent.

Exclusion criteria:

  • HbA1c less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) or greater than (>) 11% (> 97 mmol/mol)
  • History of type 2 diabetes mellitus for less than 1 year before screening
  • Less than 6 months before screening with non-insulin antihyperglycemic treatment
  • Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening
  • Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit
  • Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)
  • Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period

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 840324
  • Investigational Site Number 840273
  • Investigational Site Number 840217
  • Investigational Site Number 840220
  • Investigational Site Number 840211
  • Investigational Site Number 840207
  • Investigational Site Number 840264
  • Investigational Site Number 840234
  • Investigational Site Number 840304
  • Investigational Site Number 840347
  • Investigational Site Number 840244
  • Investigational Site Number 840257
  • Investigational Site Number 840213
  • Investigational Site Number 840267
  • Investigational Site Number 840230
  • Investigational Site Number 840235
  • Investigational Site Number 840274
  • Investigational Site Number 840222
  • Investigational Site Number 840243
  • Investigational Site Number 840250
  • Investigational Site Number 840209
  • Investigational Site Number 840297
  • Investigational Site Number 840272
  • Investigational Site Number 840223
  • Investigational Site Number 840249
  • Investigational Site Number 840331
  • Investigational Site Number 840299
  • Investigational Site Number 840285
  • Investigational Site Number 840221
  • Investigational Site Number 840233
  • Investigational Site Number 840212
  • Investigational Site Number 840266
  • Investigational Site Number 840204
  • Investigational Site Number 840248
  • Investigational Site Number 840226
  • Investigational Site Number 840318
  • Investigational Site Number 840224
  • Investigational Site Number 840337
  • Investigational Site Number 840228
  • Investigational Site Number 840238
  • Investigational Site Number 840302
  • Investigational Site Number 840227
  • Investigational Site Number 840303
  • Investigational Site Number 840225
  • Investigational Site Number 840291
  • Investigational Site Number 840316
  • Investigational Site Number 840216
  • Investigational Site Number 840332
  • Investigational Site Number 840288
  • Investigational Site Number 840325
  • Investigational Site Number 840309
  • Investigational Site Number 840251
  • Investigational Site Number 840339
  • Investigational Site Number 840245
  • Investigational Site Number 840323
  • Investigational Site Number 840236
  • Investigational Site Number 840283
  • Investigational Site Number 840278
  • Investigational Site Number 840320
  • Investigational Site Number 840276
  • Investigational Site Number 840314
  • Investigational Site Number 840317
  • Investigational Site Number 840214
  • Investigational Site Number 840232
  • Investigational Site Number 840287
  • Investigational Site Number 840344
  • Investigational Site Number 840231
  • Investigational Site Number 840348
  • Investigational Site Number 840290
  • Investigational Site Number 840208
  • Investigational Site Number 840301
  • Investigational Site Number 840289
  • Investigational Site Number 840253
  • Investigational Site Number 840270
  • Investigational Site Number 840300
  • Investigational Site Number 840210
  • Investigational Site Number 840263
  • Investigational Site Number 840349
  • Investigational Site Number 840201
  • Investigational Site Number 840256
  • Investigational Site Number 840306
  • Investigational Site Number 840203
  • Investigational Site Number 840295
  • Investigational Site Number 840269
  • Investigational Site Number 840310
  • Investigational Site Number 840247
  • Investigational Site Number 840296
  • Investigational Site Number 840275
  • Investigational Site Number 840330
  • Investigational Site Number 840307
  • Investigational Site Number 840229
  • Investigational Site Number 840219
  • Investigational Site Number 840240
  • Investigational Site Number 840308
  • Investigational Site Number 840252
  • Investigational Site Number 840237
  • Investigational Site Number 840294
  • Investigational Site Number 840260
  • Investigational Site Number 840262
  • Investigational Site Number 840342
  • Investigational Site Number 840268
  • Investigational Site Number 840292
  • Investigational Site Number 840315
  • Investigational Site Number 840242
  • Investigational Site Number 840326
  • Investigational Site Number 840338
  • Investigational Site Number 840218
  • Investigational Site Number 840328
  • Investigational Site Number 840259
  • Investigational Site Number 840327
  • Investigational Site Number 840282
  • Investigational Site Number 840202
  • Investigational Site Number 840343
  • Investigational Site Number 840239
  • Investigational Site Number 840206
  • Investigational Site Number 840246
  • Investigational Site Number 840311
  • Investigational Site Number 100205
  • Investigational Site Number 100203
  • Investigational Site Number 100201
  • Investigational Site Number 100204
  • Investigational Site Number 100206
  • Investigational Site Number 124204
  • Investigational Site Number 124211
  • Investigational Site Number 124208
  • Investigational Site Number 124214
  • Investigational Site Number 124210
  • Investigational Site Number 124218
  • Investigational Site Number 124206
  • Investigational Site Number 124219
  • Investigational Site Number 124201
  • Investigational Site Number 124209
  • Investigational Site Number 124212
  • Investigational Site Number 124216
  • Investigational Site Number 203201
  • Investigational Site Number 203205
  • Investigational Site Number 203204
  • Investigational Site Number 203203
  • Investigational Site Number 203202
  • Investigational Site Number 208203
  • Investigational Site Number 208209
  • Investigational Site Number 208202
  • Investigational Site Number 208206
  • Investigational Site Number 208210
  • Investigational Site Number 208207
  • Investigational Site Number 208201
  • Investigational Site Number 208204
  • Investigational Site Number 208205
  • Investigational Site Number 233204
  • Investigational Site Number 233203
  • Investigational Site Number 233205
  • Investigational Site Number 246208
  • Investigational Site Number 246202
  • Investigational Site Number 246207
  • Investigational Site Number 246206
  • Investigational Site Number 246205
  • Investigational Site Number 348205
  • Investigational Site Number 348201
  • Investigational Site Number 348207
  • Investigational Site Number 348212
  • Investigational Site Number 348210
  • Investigational Site Number 348202
  • Investigational Site Number 392214
  • Investigational Site Number 392215
  • Investigational Site Number 392206
  • Investigational Site Number 392217
  • Investigational Site Number 392210
  • Investigational Site Number 392208
  • Investigational Site Number 392205
  • Investigational Site Number 392203
  • Investigational Site Number 392216
  • Investigational Site Number 392213
  • Investigational Site Number 392218
  • Investigational Site Number 392204
  • Investigational Site Number 428206
  • Investigational Site Number 428203
  • Investigational Site Number 428205
  • Investigational Site Number 428202
  • Investigational Site Number 428201
  • Investigational Site Number 440203
  • Investigational Site Number 440204
  • Investigational Site Number 440201
  • Investigational Site Number 440202
  • Investigational Site Number 440205
  • Investigational Site Number 528204
  • Investigational Site Number 528209
  • Investigational Site Number 528205
  • Investigational Site Number 528207
  • Investigational Site Number 528203
  • Investigational Site Number 528202
  • Investigational Site Number 840709
  • Investigational Site Number 840706
  • Investigational Site Number 840704
  • Investigational Site Number 840710
  • Investigational Site Number 840703
  • Investigational Site Number 840708
  • Investigational Site Number 642208
  • Investigational Site Number 642212
  • Investigational Site Number 642201
  • Investigational Site Number 642202
  • Investigational Site Number 642213
  • Investigational Site Number 642207
  • Investigational Site Number 642205
  • Investigational Site Number 642203
  • Investigational Site Number 642204
  • Investigational Site Number 642206
  • Investigational Site Number 642209
  • Investigational Site Number 703205
  • Investigational Site Number 703202
  • Investigational Site Number 703203
  • Investigational Site Number 703201
  • Investigational Site Number 703206
  • Investigational Site Number 703207
  • Investigational Site Number 752205
  • Investigational Site Number 752206
  • Investigational Site Number 752201
  • Investigational Site Number 752204

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
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Secondary Outcome Measures

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6
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]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.
Change in 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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Variability of Preinjection SMPG at 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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Percentage of Participants With HbA1c <7% at Month 6
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6
Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Change in Daily Basal Insulin Dose From Baseline to Month 6
Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in Total 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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
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
August 28, 2012
Last Updated
May 28, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01676220
Brief Title
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
Acronym
EDITION III
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® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
March 2014 (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 compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: - occurrence of nocturnal hypoglycemia
Detailed Description
The maximum study duration was up to approximately 54 weeks per participant, consisting of: Up to 2 week screening period; it can be exceptionally extended of up to one additional week 6-month comparative efficacy and safety treatment period 6-month comparative safety extension period 2-day post-treatment safety follow-up period

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
878 (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 non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).
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 non-insulin antihyperglycemic drug(s). 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
Description
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
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
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]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.
Time Frame
Week 9 Up to Month 6
Title
Change in 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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame
Baseline, Month 6
Title
Variability of Preinjection SMPG at 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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame
Month 6
Title
Percentage of Participants With HbA1c <7% at Month 6
Description
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame
Month 6
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Description
Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame
Baseline, Month 6
Title
Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6
Description
Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame
Month 6
Title
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame
Baseline, Month 6
Title
Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
Description
Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame
Baseline, Month 6
Title
Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
Description
Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Time Frame
Baseline, Month 6
Title
Change in Daily Basal Insulin Dose From Baseline to Month 6
Description
Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Time Frame
Baseline, Month 6
Title
Change in Total 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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
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 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s); Signed written informed consent. Exclusion criteria: HbA1c less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) or greater than (>) 11% (> 97 mmol/mol) History of type 2 diabetes mellitus for less than 1 year before screening Less than 6 months before screening with non-insulin antihyperglycemic treatment Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline) Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period 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 840324
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36109
Country
United States
Facility Name
Investigational Site Number 840273
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigational Site Number 840217
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Investigational Site Number 840220
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Investigational Site Number 840211
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Investigational Site Number 840207
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Investigational Site Number 840264
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Investigational Site Number 840234
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Investigational Site Number 840304
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840347
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Investigational Site Number 840244
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Investigational Site Number 840257
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site Number 840213
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigational Site Number 840267
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Investigational Site Number 840230
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840235
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840274
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840222
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigational Site Number 840243
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigational Site Number 840250
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Investigational Site Number 840209
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Investigational Site Number 840297
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Investigational Site Number 840272
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Investigational Site Number 840223
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Investigational Site Number 840249
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Investigational Site Number 840331
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
Investigational Site Number 840299
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Investigational Site Number 840285
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Investigational Site Number 840221
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Investigational Site Number 840233
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Investigational Site Number 840212
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigational Site Number 840266
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigational Site Number 840204
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Investigational Site Number 840248
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigational Site Number 840226
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Investigational Site Number 840318
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 840224
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Investigational Site Number 840337
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Facility Name
Investigational Site Number 840228
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Investigational Site Number 840238
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Investigational Site Number 840302
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigational Site Number 840227
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840303
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Investigational Site Number 840225
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Investigational Site Number 840291
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site Number 840316
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 840216
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Investigational Site Number 840332
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840288
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Investigational Site Number 840325
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigational Site Number 840309
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Investigational Site Number 840251
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Investigational Site Number 840339
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Investigational Site Number 840245
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Investigational Site Number 840323
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Investigational Site Number 840236
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Investigational Site Number 840283
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840278
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Investigational Site Number 840320
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number 840276
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Investigational Site Number 840314
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840317
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigational Site Number 840214
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Investigational Site Number 840232
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Investigational Site Number 840287
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Investigational Site Number 840344
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Investigational Site Number 840231
City
Murray
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Investigational Site Number 840348
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigational Site Number 840290
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Investigational Site Number 840208
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840301
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840289
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Investigational Site Number 840253
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
1830
Country
United States
Facility Name
Investigational Site Number 840270
City
Madison Heights
State/Province
Michigan
ZIP/Postal Code
48071
Country
United States
Facility Name
Investigational Site Number 840300
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Investigational Site Number 840210
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number 840263
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number 840349
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Investigational Site Number 840201
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigational Site Number 840256
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigational Site Number 840306
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
Investigational Site Number 840203
City
Sea Girt
State/Province
New Jersey
ZIP/Postal Code
08750
Country
United States
Facility Name
Investigational Site Number 840295
City
Sicklerville
State/Province
New Jersey
ZIP/Postal Code
08081
Country
United States
Facility Name
Investigational Site Number 840269
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Investigational Site Number 840310
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Investigational Site Number 840247
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Investigational Site Number 840296
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Investigational Site Number 840275
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Investigational Site Number 840330
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Investigational Site Number 840307
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site Number 840229
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Investigational Site Number 840219
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Investigational Site Number 840240
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Investigational Site Number 840308
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Investigational Site Number 840252
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigational Site Number 840237
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Investigational Site Number 840294
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Investigational Site Number 840260
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Investigational Site Number 840262
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigational Site Number 840342
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Investigational Site Number 840268
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840292
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840315
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840242
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840326
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Investigational Site Number 840338
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Investigational Site Number 840218
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Investigational Site Number 840328
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Investigational Site Number 840259
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Investigational Site Number 840327
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Investigational Site Number 840282
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 840202
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Investigational Site Number 840343
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Investigational Site Number 840239
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Investigational Site Number 840206
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Investigational Site Number 840246
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Investigational Site Number 840311
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
Investigational Site Number 100205
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Investigational Site Number 100203
City
Byala
ZIP/Postal Code
7100
Country
Bulgaria
Facility Name
Investigational Site Number 100201
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Investigational Site Number 100204
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Investigational Site Number 100206
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigational Site Number 124204
City
Brampton
ZIP/Postal Code
L6R 3J5
Country
Canada
Facility Name
Investigational Site Number 124211
City
Etobicoke
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Investigational Site Number 124208
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Investigational Site Number 124214
City
London
ZIP/Postal Code
N6A 5G6
Country
Canada
Facility Name
Investigational Site Number 124210
City
Montreal
ZIP/Postal Code
H1Y 3L1
Country
Canada
Facility Name
Investigational Site Number 124218
City
Montreal
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
Investigational Site Number 124206
City
Pointe-Claire
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Investigational Site Number 124219
City
Sherbrooke
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Investigational Site Number 124201
City
Thornhill
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Investigational Site Number 124209
City
Thornhill
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Investigational Site Number 124212
City
Toronto
ZIP/Postal Code
M9W 4L9
Country
Canada
Facility Name
Investigational Site Number 124216
City
Ville St-Laurent
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Investigational Site Number 203201
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Investigational Site Number 203205
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Investigational Site Number 203204
City
Havirov
ZIP/Postal Code
73601
Country
Czech Republic
Facility Name
Investigational Site Number 203203
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Investigational Site Number 203202
City
Praha 8
ZIP/Postal Code
18100
Country
Czech Republic
Facility Name
Investigational Site Number 208203
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Investigational Site Number 208209
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Investigational Site Number 208202
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Investigational Site Number 208206
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Investigational Site Number 208210
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Investigational Site Number 208207
City
København Nv
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Investigational Site Number 208201
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number 208204
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Investigational Site Number 208205
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Investigational Site Number 233204
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site Number 233203
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Investigational Site Number 233205
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
Investigational Site Number 246208
City
Helsinki
ZIP/Postal Code
260
Country
Finland
Facility Name
Investigational Site Number 246202
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Investigational Site Number 246207
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Investigational Site Number 246206
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Investigational Site Number 246205
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Investigational Site Number 348205
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Investigational Site Number 348201
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Investigational Site Number 348207
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Investigational Site Number 348212
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Investigational Site Number 348210
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 348202
City
Urhida
ZIP/Postal Code
8142
Country
Hungary
Facility Name
Investigational Site Number 392214
City
Fujimi
Country
Japan
Facility Name
Investigational Site Number 392215
City
Fujimi
Country
Japan
Facility Name
Investigational Site Number 392206
City
Ise-Shi
Country
Japan
Facility Name
Investigational Site Number 392217
City
Kitaazumi-Gun
Country
Japan
Facility Name
Investigational Site Number 392210
City
Matsumoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392208
City
Matumoto
Country
Japan
Facility Name
Investigational Site Number 392205
City
Midori-Shi
Country
Japan
Facility Name
Investigational Site Number 392203
City
Mito-Shi
Country
Japan
Facility Name
Investigational Site Number 392216
City
Sakai
Country
Japan
Facility Name
Investigational Site Number 392213
City
Shimotsuke
Country
Japan
Facility Name
Investigational Site Number 392218
City
Shunan-Shi
Country
Japan
Facility Name
Investigational Site Number 392204
City
Yamagata-Shi
Country
Japan
Facility Name
Investigational Site Number 428206
City
Riga
ZIP/Postal Code
1024
Country
Latvia
Facility Name
Investigational Site Number 428203
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number 428205
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
Facility Name
Investigational Site Number 428202
City
Sigulda
ZIP/Postal Code
LV-2150
Country
Latvia
Facility Name
Investigational Site Number 428201
City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Investigational Site Number 440203
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Facility Name
Investigational Site Number 440204
City
Kaunas
ZIP/Postal Code
LT-49456
Country
Lithuania
Facility Name
Investigational Site Number 440201
City
Klaipeda
ZIP/Postal Code
LT-92253
Country
Lithuania
Facility Name
Investigational Site Number 440202
City
Klaipeda
ZIP/Postal Code
LT-92304
Country
Lithuania
Facility Name
Investigational Site Number 440205
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Investigational Site Number 528204
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
Investigational Site Number 528209
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Facility Name
Investigational Site Number 528205
City
Breda
ZIP/Postal Code
4811 SW
Country
Netherlands
Facility Name
Investigational Site Number 528207
City
Leiderdorp
ZIP/Postal Code
2352 RA
Country
Netherlands
Facility Name
Investigational Site Number 528203
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Investigational Site Number 528202
City
Velp
ZIP/Postal Code
6883 ES
Country
Netherlands
Facility Name
Investigational Site Number 840709
City
Cagua
ZIP/Postal Code
725
Country
Puerto Rico
Facility Name
Investigational Site Number 840706
City
Carolina
ZIP/Postal Code
987
Country
Puerto Rico
Facility Name
Investigational Site Number 840704
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Investigational Site Number 840710
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Investigational Site Number 840703
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Facility Name
Investigational Site Number 840708
City
San Juan
ZIP/Postal Code
926
Country
Puerto Rico
Facility Name
Investigational Site Number 642208
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Investigational Site Number 642212
City
Bucuresti
ZIP/Postal Code
020359
Country
Romania
Facility Name
Investigational Site Number 642201
City
Bucuresti
ZIP/Postal Code
20475
Country
Romania
Facility Name
Investigational Site Number 642202
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Investigational Site Number 642213
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642207
City
Resita
ZIP/Postal Code
320076
Country
Romania
Facility Name
Investigational Site Number 642205
City
Sibiu
ZIP/Postal Code
550371
Country
Romania
Facility Name
Investigational Site Number 642203
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 642204
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 642206
City
Timisoara
ZIP/Postal Code
300133
Country
Romania
Facility Name
Investigational Site Number 642209
City
Timisoara
ZIP/Postal Code
300456
Country
Romania
Facility Name
Investigational Site Number 703205
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Investigational Site Number 703202
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Investigational Site Number 703203
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Investigational Site Number 703201
City
Levice
ZIP/Postal Code
93405
Country
Slovakia
Facility Name
Investigational Site Number 703206
City
Levice
ZIP/Postal Code
95401
Country
Slovakia
Facility Name
Investigational Site Number 703207
City
Lucenec
ZIP/Postal Code
98401
Country
Slovakia
Facility Name
Investigational Site Number 752205
City
Kristianstad
ZIP/Postal Code
29185
Country
Sweden
Facility Name
Investigational Site Number 752206
City
Malmö
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Investigational Site Number 752201
City
Stockholm
ZIP/Postal Code
11526
Country
Sweden
Facility Name
Investigational Site Number 752204
City
Vällingby
ZIP/Postal Code
16268
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25641260
Citation
Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.
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
30160030
Citation
Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.
Results Reference
derived
PubMed Identifier
29370218
Citation
Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.
Results Reference
derived

Learn more about this trial

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

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