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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: HOE901-U300 (new formulation of insulin glargine); Drug: Lantus (insulin glargine)

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

• Study Type: Interventional
• Enrollment (Actual): 878
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HOE901-U300	Drug: HOE901-U300 (new formulation of insulin glargine); 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]).
Active Comparator: Lantus	Drug: Lantus (insulin glargine); 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).; Other Names: Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 9 Up to Month 6
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.	Baseline, Month 6
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.	Month 6
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.	Month 6
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.	Baseline, Month 6
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.	Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
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).	Up to 12 months

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: EFC12347; 2012-000146-35 (EudraCT Number); U1111-1124-5261 (Other Identifier: UTN)