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

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

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

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 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

• Study Type: Interventional
• Enrollment (Actual): 807
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Beamsville, Canada, L0R 1B0
    • Investigational Site Number 124024
  • Burlington, Canada, L7M 4Y1
    • Investigational Site Number 124025
  • Calgary, Canada, T2H 2G4
    • Investigational Site Number 124023
  • Calgary, Canada, T2N 4L7
    • Investigational Site Number 124020
  • Chatham, Canada, N7L 1C1
    • Investigational Site Number 124019
  • Coquitlam, Canada, V3K 3P4
    • Investigational Site Number 124018
  • Hamilton, Canada, L8L 5G8
    • Investigational Site Number 124021
  • Hamilton, Canada, L8N 3Z5
    • Investigational Site Number 124014
  • Laval, Canada, H7T 2P5
    • Investigational Site Number 124006
  • London, Canada, N6A 4V2
    • Investigational Site Number 124009
  • Mississauga, Canada, L5M 2V8
    • Investigational Site Number 124008
  • Montreal, Canada, H2W 1R7
    • Investigational Site Number 124015
  • Montreal, Canada, H2W 1T8
    • Investigational Site Number 124004
  • Oshawa, Canada, L1H 7K4
    • Investigational Site Number 124005
  • Quebec, Canada, G1V 4G5
    • Investigational Site Number 124026
  • Red Deer, Canada, T4N 6V7
    • Investigational Site Number 124002
  • Thornhill, Canada, L4J 8L7
    • Investigational Site Number 124007
  • Toronto, Canada, M4G 3E8
    • Investigational Site Number 124001
  • Toronto, Canada, M5C 2T2
    • Investigational Site Number 124011
  • Victoria, Canada, V8V 4A1
    • Investigational Site Number 124010
  • Ville St-Laurent, Canada, H4T 1Z9
    • Investigational Site Number 124017
  • Winnipeg, Canada, R3E 3P4
    • Investigational Site Number 124022
• Czechia
  • Beroun, Czechia, 26601
    • Investigational Site Number 203006
  • Breclav, Czechia, 690 02
    • Investigational Site Number 203001
  • Hodonin, Czechia, 69501
    • Investigational Site Number 203002
  • Holesov, Czechia, 76901
    • Investigational Site Number 203009
  • Hradec Kralove, Czechia, 50005
    • Investigational Site Number 203003
  • Hranice, Czechia, 75301
    • Investigational Site Number 203007
  • Krnov, Czechia, 79401
    • Investigational Site Number 203004
  • Olomouc, Czechia, 77900
    • Investigational Site Number 203010
  • Praha 2, Czechia, 12808
    • Investigational Site Number 203008
  • Prostejov, Czechia, 79601
    • Investigational Site Number 203005
• Estonia
  • Pärnu, Estonia, 80018
    • Investigational Site Number 233002
  • Tallinn, Estonia, 11313
    • Investigational Site Number 233004
  • Tallinn, Estonia, 11913
    • Investigational Site Number 233006
  • Tallinn, Estonia, 13415
    • Investigational Site Number 233003
  • Tallinn, Estonia, 13419
    • Investigational Site Number 233001
  • Tartu, Estonia, 50410
    • Investigational Site Number 233005
• Finland
  • Helsinki, Finland, 00260
    • Investigational Site Number 246001
  • Kuopio, Finland, 70210
    • Investigational Site Number 246005
  • Oulu, Finland, 90100
    • Investigational Site Number 246002
• France
  • La Rochelle Cedex, France, 17019
    • Investigational Site Number 250004
  • Strasbourg, France, 67091
    • Investigational Site Number 250002
• Germany
  • Heidelberg, Germany, 69115
    • Investigational Site Number 276006
  • Riesa, Germany, 01587
    • Investigational Site Number 276002
  • Schwabenheim, Germany, 55270
    • Investigational Site Number 276003
• Hungary
  • Baja, Hungary, 6500
    • Investigational Site Number 348010
  • Balatonfüred, Hungary, 8230
    • Investigational Site Number 348004
  • Budapest, Hungary, 1083
    • Investigational Site Number 348015
  • Budapest, Hungary, 1088
    • Investigational Site Number 348013
  • Budapest, Hungary, 1134
    • Investigational Site Number 348017
  • Budapest, Hungary, 1139
    • Investigational Site Number 348009
  • Budapest, Hungary
    • Investigational Site Number 348002
  • Debrecen, Hungary, 4043
    • Investigational Site Number 348005
  • Eger, Hungary, 3300
    • Investigational Site Number 348008
  • Gyula, Hungary, 5700
    • Investigational Site Number 348018
  • Makó, Hungary, 6900
    • Investigational Site Number 348014
  • Mosonmagyaróvár, Hungary, 9200
    • Investigational Site Number 348012
  • Nyiregyháza, Hungary, 4400
    • Investigational Site Number 348007
  • Szeged, Hungary, 6722
    • Investigational Site Number 348003
  • Szombathely, Hungary, 9700
    • Investigational Site Number 348006
  • Sátorlaljaújhely, Hungary, 3980
    • Investigational Site Number 348011
  • Zalaegerszeg, Hungary, 8900
    • Investigational Site Number 348001
• Latvia
  • Jekabpils, Latvia, LV-5201
    • Investigational Site Number 428006
  • Ogre, Latvia, LV-5001
    • Investigational Site Number 428005
  • Riga, Latvia, LV-1002
    • Investigational Site Number 428002
  • Riga, Latvia, LV-1038
    • Investigational Site Number 428001
  • Riga, Latvia, LV-1050
    • Investigational Site Number 428004
  • Sigulda, Latvia, LV-2150
    • Investigational Site Number 428003
• Mexico
  • Chihuahua, Mexico, 31000
    • Investigational Site Number 484007
  • Cuernavaca, Mexico, 62250
    • Investigational Site Number 484001
  • Guadalajara, Mexico, 44670
    • Investigational Site Number 484006
  • Monterrey, Mexico, 64460
    • Investigational Site Number 484003
  • Pachuca, Mexico, 42060
    • Investigational Site Number 484004
• Netherlands
  • Almelo, Netherlands, 7609 PP
    • Investigational Site Number 528009
  • Eindhoven, Netherlands, 5631 BM
    • Investigational Site Number 528004
  • Groningen, Netherlands, 9728 NT
    • Investigational Site Number 528007
  • Hoogeveen, Netherlands, 7909 AA
    • Investigational Site Number 528005
  • Hoorn, Netherlands, 1064NP
    • Investigational Site Number 528001
  • Leeuwarden, Netherlands, 8934 AD
    • Investigational Site Number 528008
  • Utrecht, Netherlands, 3563 AZ
    • Investigational Site Number 528006
  • Venlo, Netherlands, 5912 BL
    • Investigational Site Number 528002
• Romania
  • Bacau, Romania, 600114
    • Investigational Site Number 642001
  • Bucuresti, Romania, 020475
    • Investigational Site Number 642005
  • Bucuresti, Romania, 700164
    • Investigational Site Number 642006
  • Cluj Napoca, Romania, 400006
    • Investigational Site Number 642002
  • Iasi, Romania, 700547
    • Investigational Site Number 642004
  • Iasi, Romania, 700613
    • Investigational Site Number 642008
  • Oradea, Romania, 410169
    • Investigational Site Number 642003
  • Targu Mures, Romania, 540142
    • Investigational Site Number 642009
  • Timisoara, Romania, 300133
    • Investigational Site Number 642007
• South Africa
  • Alberton, South Africa, 1450
    • Investigational Site Number 710005
  • Johannesburg, South Africa, 2198
    • Investigational Site Number 710003
  • Lenasia, South Africa, 1820
    • Investigational Site Number 710006
  • Observatory, South Africa, 7925
    • Investigational Site Number 710002
  • Paarl, South Africa, 7500
    • Investigational Site Number 710001
  • Pretoria, South Africa, 0167
    • Investigational Site Number 710008
  • Somerset West, South Africa, 7130
    • Investigational Site Number 710004
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Investigational Site Number 840156
    • Glendale, Arizona, United States, 85306
      • Investigational Site Number 840102
    • Phoenix, Arizona, United States, 85028
      • Investigational Site Number 840071
    • Sun City, Arizona, United States, 85351
      • Investigational Site Number 840121
    • Tempe, Arizona, United States, 85282
      • Investigational Site Number 840070
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Investigational Site Number 840016
    • Little Rock, Arkansas, United States, 72205
      • Investigational Site Number 840015
    • Little Rock, Arkansas, United States, 72205
      • Investigational Site Number 840124
    • Searcy, Arkansas, United States, 72143
      • Investigational Site Number 840032
  • California
    • Anaheim, California, United States, 92801
      • Investigational Site Number 840076
    • Encino, California, United States, 91436
      • Investigational Site Number 840133
    • Greenbrae, California, United States, 94904
      • Investigational Site Number 840062
    • Huntington Beach, California, United States, 92648
      • Investigational Site Number 840057
    • La Jolla, California, United States, 92037
      • Investigational Site Number 840059
    • La Mesa, California, United States, 91942
      • Investigational Site Number 840004
    • Mission Hills, California, United States, 91345
      • Investigational Site Number 840099
    • Palm Springs, California, United States, 92262
      • Investigational Site Number 840107
    • San Diego, California, United States, 92161
      • Investigational Site Number 840005
    • Tustin, California, United States, 92780
      • Investigational Site Number 840013
    • Walnut Creek, California, United States, 94598
      • Investigational Site Number 840002
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Investigational Site Number 840114
    • Colorado Springs, Colorado, United States, 80910
      • Investigational Site Number 840136
    • Longmont, Colorado, United States, 80501
      • Investigational Site Number 840092
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Investigational Site Number 840049
    • Hollywood, Florida, United States, 33021
      • Investigational Site Number 840050
    • Jacksonville, Florida, United States, 32204
      • Investigational Site Number 840086
    • Jacksonville, Florida, United States, 32216
      • Investigational Site Number 840011
    • Jacksonville, Florida, United States, 32258
      • Investigational Site Number 840009
    • New Port Richey, Florida, United States, 34652
      • Investigational Site Number 840023
    • Ocoee, Florida, United States, 34761
      • Investigational Site Number 840012
    • Palm Harbor, Florida, United States, 34684
      • Investigational Site Number 840148
  • Georgia
    • Lawrenceville, Georgia, United States, 30045
      • Investigational Site Number 840055
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Investigational Site Number 840052
    • Nampa, Idaho, United States, 83686
      • Investigational Site Number 840117
  • Illinois
    • McHenry, Illinois, United States, 60050
      • Investigational Site Number 840020
    • Springfield, Illinois, United States, 62704
      • Investigational Site Number 840019
  • Indiana
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 840078
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 840089
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 840097
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 840098
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 840100
    • Vincennes, Indiana, United States, 47591
      • Investigational Site Number 840127
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Investigational Site Number 840116
  • Kansas
    • Wichita, Kansas, United States, 67211
      • Investigational Site Number 840003
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Investigational Site Number 840080
    • Paducah, Kentucky, United States, 42003
      • Investigational Site Number 840042
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Investigational Site Number 840036
    • Baltimore, Maryland, United States, 21237
      • Investigational Site Number 840155
    • Rockville, Maryland, United States, 20852
      • Investigational Site Number 840034
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Investigational Site Number 840065
    • Dearborn, Michigan, United States, 48124
      • Investigational Site Number 840066
    • Flint, Michigan, United States, 48504
      • Investigational Site Number 840103
    • Kalamazoo, Michigan, United States, 49048
      • Investigational Site Number 840126
    • Southfield, Michigan, United States, 48034
      • Investigational Site Number 840022
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Investigational Site Number 840143
    • Eagan, Minnesota, United States, 55122
      • Investigational Site Number 840068
    • Minneapolis, Minnesota, United States, 55416
      • Investigational Site Number 840085
  • Montana
    • Kalispell, Montana, United States, 59901
      • Investigational Site Number 840053
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Investigational Site Number 840090
    • Omaha, Nebraska, United States, 68130
      • Investigational Site Number 840091
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Investigational Site Number 840058
  • New Jersey
    • Brick, New Jersey, United States, 08274
      • Investigational Site Number 840043
    • Toms River, New Jersey, United States, 08721
      • Investigational Site Number 840152
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Investigational Site Number 840146
    • Hickory, North Carolina, United States, 28601
      • Investigational Site Number 840145
    • Wilmington, North Carolina, United States, 28401
      • Investigational Site Number 840045
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Investigational Site Number 840067
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Investigational Site Number 840008
    • Columbus, Ohio, United States, 43213
      • Investigational Site Number 840106
    • Dayton, Ohio, United States, 45439
      • Investigational Site Number 840123
    • Maumee, Ohio, United States, 43537
      • Investigational Site Number 840119
    • Mentor, Ohio, United States, 44060
      • Investigational Site Number 840122
  • Oregon
    • Medford, Oregon, United States, 97504
      • Investigational Site Number 840083
    • Portland, Oregon, United States, 97239-3098
      • Investigational Site Number 840084
  • Pennsylvania
    • Uniontown, Pennsylvania, United States, 15401
      • Investigational Site Number 840007
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Investigational Site Number 840079
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Investigational Site Number 840048
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Investigational Site Number 840039
    • Knoxville, Tennessee, United States, 37912
      • Investigational Site Number 840159
  • Texas
    • Austin, Texas, United States, 78731
      • Investigational Site Number 840021
    • Austin, Texas, United States, 78731
      • Investigational Site Number 840129
    • Austin, Texas, United States, 78758
      • Investigational Site Number 840081
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 840001
    • Dallas, Texas, United States, 75246
      • Investigational Site Number 840047
    • Houston, Texas, United States, 77096
      • Investigational Site Number 840082
    • Hurst, Texas, United States, 76054
      • Investigational Site Number 840120
  • Utah
    • Draper, Utah, United States, 84020
      • Investigational Site Number 840010
    • Ogden, Utah, United States, 84403
      • Investigational Site Number 840060
  • Virginia
    • Chesapeake, Virginia, United States, 23321
      • Investigational Site Number 840035
    • Norfolk, Virginia, United States, 23502
      • Investigational Site Number 840074
    • Norfolk, Virginia, United States, 23507
      • Investigational Site Number 840112
    • Norfolk, Virginia, United States, 23510
      • Investigational Site Number 840041
    • Richmond, Virginia, United States, 23235
      • Investigational Site Number 840104
    • Williamsburg, Virginia, United States, 23185
      • Investigational Site Number 840075
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209-0996
      • Investigational Site Number 840018

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 :

• 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.

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 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.
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 mealtime insulin analogue. 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	Time Frame
Change in HbA1c From Baseline to Month 6 Endpoint	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 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]).	Week 9 Up to Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
Percentage of Participants With HbA1c <7% at Month 6 Endpoint		Month 6
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint		Baseline, Month 6
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint		Month 6
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.	Baseline, Month 6
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint		Baseline, Month 6
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.	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 Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c From Month 6 to Month 9	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.	Month 6 Up to Month 9

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

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: EFC11628; 2010-023769-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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