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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01676220
First received: August 28, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 patients with type 2 diabetes mellitus.

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of:

  • occurrence of nocturnal hypoglycemia
  • change in pre-injection plasma glucose,
  • change in variability of pre-injection plasma glucose

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin glargine new formulation (HOE901)
Drug: Insulin glargine (HOE901)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence (%) of patients with at least one nocturnal hypoglycemia, indicated as severe and/or confirmed by plasma glucose ≤ 70 mg/dL(3.9 mmol/L) occurred from week9 to endpoint [ Time Frame: week 9, 6 months ] [ Designated as safety issue: No ]
  • Change in pre-injection plasma glucose from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in variability of pre-injection plasma glucose (coefficient of variation over 7 days) from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with HbA1c <7 % at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with FPG <100 mg/dL [ Time Frame: 12 weeks, 6 month ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in 8-point SMPG profiles per time-point from baseline to endpoint [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change of mean 24h plasma glucose (based on 8-point SMPG profiles) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in variability in mean 24h plasma glucose (based on 8-point SMPG profiles) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in daily basal insulin dose from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) [ Time Frame: baseline, up to 6 months ] [ Designated as safety issue: No ]
  • Number of Patients with various types of Hypoglycemia Events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 881
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine - new formulation
once daily on top of non-insulin antihyperglycemic drugs
Drug: Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Active Comparator: Lantus (Insulin glargine)
once daily on top of non-insulin antihyperglycemic drugs
Drug: Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Name: Lantus

Detailed Description:

The maximum study duration will be 54 weeks per patient, 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

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

Exclusion criteria:

  • HbA1c < 7.0% (< 53 mmol/mol) or > 11% (> 97 mmol/mol) [at screening];
  • 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 GLP-1 receptor agonist in the last 6 months before screening visit;
  • Patients 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 (e.g. 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 (e.g. laser, surgical treatment or injectable drugs) during the study period.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676220

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840324
Montgomery, Alabama, United States, 36109
United States, Arizona
Investigational Site Number 840273
Chandler, Arizona, United States, 85224
Investigational Site Number 840217
Mesa, Arizona, United States, 85206
Investigational Site Number 840220
Peoria, Arizona, United States, 85050
Investigational Site Number 840211
Phoenix, Arizona, United States, 85028
Investigational Site Number 840207
Phoenix, Arizona, United States, 85050
Investigational Site Number 840264
Tempe, Arizona, United States, 85282
Investigational Site Number 840234
Tempe, Arizona, United States
United States, Arkansas
Investigational Site Number 840304
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840347
Bell Gardens, California, United States, 90201
Investigational Site Number 840244
Escondido, California, United States, 92025
Investigational Site Number 840257
Fresno, California, United States, 93720
Investigational Site Number 840213
Greenbrae, California, United States, 94904
Investigational Site Number 840267
Huntington Beach, California, United States, 92648
Investigational Site Number 840230
La Jolla, California, United States, 92037
Investigational Site Number 840235
La Jolla, California, United States, 92037-1205
Investigational Site Number 840274
La Mesa, California, United States, 91942
Investigational Site Number 840222
Long Beach, California, United States, 90806
Investigational Site Number 840243
Palm Springs, California, United States, 92262
Investigational Site Number 840250
Spring Valley, California, United States, 91978
Investigational Site Number 840209
Temecula, California, United States, 92591
Investigational Site Number 840297
Torrance, California, United States, 90502
Investigational Site Number 840272
Tustin, California, United States, 92780
Investigational Site Number 840223
Walnut Creek, California, United States, 94598
United States, Colorado
Investigational Site Number 840249
Colorado Springs, Colorado, United States, 80907
Investigational Site Number 840331
Denver, Colorado, United States, 80212
United States, District of Columbia
Investigational Site Number 840208
Washington, District of Columbia, United States, 20003
United States, Florida
Investigational Site Number 840299
Boca Raton, Florida, United States, 33432
Investigational Site Number 840285
Boynton Beach, Florida, United States, 33472
Investigational Site Number 840221
Bradenton, Florida, United States, 34208
Investigational Site Number 840233
Clearwater, Florida, United States, 33765
Investigational Site Number 840212
Coral Gables, Florida, United States, 33134
Investigational Site Number 840266
Coral Gables, Florida, United States, 33134
Investigational Site Number 840204
Hialeah, Florida, United States, 33012
Investigational Site Number 840248
Hollywood, Florida, United States, 33021
Investigational Site Number 840318
Jacksonville, Florida, United States, 32216
Investigational Site Number 840224
Jacksonville, Florida, United States, 32258
Investigational Site Number 840226
Jacksonville, Florida, United States, 32205
Investigational Site Number 840228
Miami, Florida, United States, 33144
Investigational Site Number 840238
Miami, Florida, United States, 33144
Investigational Site Number 840302
Miami, Florida, United States, 33176
Investigational Site Number 840337
Miami Beach, Florida, United States, 33141
Investigational Site Number 840227
New Port Richey, Florida, United States, 34652
Investigational Site Number 840303
North Miami Beach, Florida, United States, 33162
Investigational Site Number 840225
Ocala, Florida, United States, 34471
Investigational Site Number 840316
Orlando, Florida, United States, 32806
Investigational Site Number 840291
Orlando, Florida, United States, 32804
Investigational Site Number 840216
Oviedo, Florida, United States, 32765
Investigational Site Number 840332
Palm Harbor, Florida, United States, 34684
Investigational Site Number 840288
Pembroke Pines, Florida, United States, 33028
Investigational Site Number 840325
Port Charlotte, Florida, United States, 33952
Investigational Site Number 840309
St. Petersburg, Florida, United States, 33716
Investigational Site Number 840251
Tampa, Florida, United States, 33603
Investigational Site Number 840339
West Palm Beach, Florida, United States, 33401
United States, Georgia
Investigational Site Number 840245
Atlanta, Georgia, United States, 30308
Investigational Site Number 840323
Stockbridge, Georgia, United States, 30281
United States, Hawaii
Investigational Site Number 840236
Honolulu, Hawaii, United States, 96814
United States, Idaho
Investigational Site Number 840283
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site Number 840278
Chicago, Illinois, United States, 60607
Investigational Site Number 840320
Chicago, Illinois, United States, 60612
Investigational Site Number 840276
Springfield, Illinois, United States, 62704
United States, Indiana
Investigational Site Number 840314
Avon, Indiana, United States, 46123
Investigational Site Number 840317
Franklin, Indiana, United States, 46131
United States, Iowa
Investigational Site Number 840214
Des Moines, Iowa, United States, 50314
United States, Kansas
Investigational Site Number 840232
Overland Park, Kansas, United States, 66210
Investigational Site Number 840287
Topeka, Kansas, United States, 66614
United States, Kentucky
Investigational Site Number 840344
Lexington, Kentucky, United States, 40503
Investigational Site Number 840231
Murray, Kentucky, United States, 42003
United States, Louisiana
Investigational Site Number 840348
Metairie, Louisiana, United States, 70006
Investigational Site Number 840290
New Orleans, Louisiana, United States, 70119
United States, Maryland
Investigational Site Number 840301
Rockville, Maryland, United States, 20852
United States, Massachusetts
Investigational Site Number 840289
Fall River, Massachusetts, United States, 02720
Investigational Site Number 840253
Haverhill, Massachusetts, United States, 1830
United States, Michigan
Investigational Site Number 840270
Madison Heights, Michigan, United States, 48071
United States, Nebraska
Investigational Site Number 840258
Lincoln, Nebraska, United States, 68516
Investigational Site Number 840263
Omaha, Nebraska, United States, 68131
Investigational Site Number 840300
Omaha, Nebraska, United States, 68105
Investigational Site Number 840210
Omaha, Nebraska, United States, 68131
United States, Nevada
Investigational Site Number 840349
Las Vegas, Nevada, United States, 89117
Investigational Site Number 840201
Las Vegas, Nevada, United States, 89119
Investigational Site Number 840256
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Investigational Site Number 840306
Hamilton, New Jersey, United States, 08619
Investigational Site Number 840203
Sea Girt, New Jersey, United States, 08750
Investigational Site Number 840295
Sicklerville, New Jersey, United States, 08081
United States, New Mexico
Investigational Site Number 840269
Albuquerque, New Mexico, United States, 87106
United States, New York
Investigational Site Number 840310
New Hyde Park, New York, United States, 11042
United States, North Carolina
Investigational Site Number 840247
Asheville, North Carolina, United States, 28803
Investigational Site Number 840205
Burlington, North Carolina, United States, 27215
Investigational Site Number 840296
Greensboro, North Carolina, United States, 27408
Investigational Site Number 840215
Greensboro, North Carolina, United States, 27401
Investigational Site Number 840271
Mooresville, North Carolina, United States, 28117
Investigational Site Number 840275
Morganton, North Carolina, United States, 28655
United States, Ohio
Investigational Site Number 840241
Akron, Ohio, United States, 44313
Investigational Site Number 840330
Cleveland, Ohio, United States, 44122
Investigational Site Number 840307
Columbus, Ohio, United States, 43213
United States, Oklahoma
Investigational Site Number 840229
Norman, Oklahoma, United States, 73069
United States, Oregon
Investigational Site Number 840219
Bend, Oregon, United States, 97701
United States, Pennsylvania
Investigational Site Number 840240
Philadelphia, Pennsylvania, United States, 19139
Investigational Site Number 840308
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Investigational Site Number 840252
Greer, South Carolina, United States, 29651
Investigational Site Number 840237
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Investigational Site Number 840294
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Investigational Site Number 840260
Bristol, Tennessee, United States, 37620
Investigational Site Number 840262
Chattanooga, Tennessee, United States, 37404
United States, Texas
Investigational Site Number 840342
Corpus Christi, Texas, United States, 78404
Investigational Site Number 840292
Dallas, Texas, United States, 75230
Investigational Site Number 840315
Dallas, Texas, United States, 75231
Investigational Site Number 840268
Dallas, Texas, United States, 75230
Investigational Site Number 840242
Dallas, Texas, United States, 75246
Investigational Site Number 840326
Edinburg, Texas, United States, 78539
Investigational Site Number 840218
Houston, Texas, United States, 77004
Investigational Site Number 840328
Houston, Texas, United States, 77074
Investigational Site Number 840259
Houston, Texas, United States, 77095
Investigational Site Number 840338
Houston, Texas, United States, 77002
Investigational Site Number 840327
Pearland, Texas, United States, 77584
Investigational Site Number 840282
San Antonio, Texas, United States, 78229
United States, Utah
Investigational Site Number 840202
Murray, Utah, United States, 84123
Investigational Site Number 840343
Salt Lake City, Utah, United States, 84107
United States, Virginia
Investigational Site Number 840239
Burke, Virginia, United States, 22015
Investigational Site Number 840206
Manassas, Virginia, United States, 20110
United States, Washington
Investigational Site Number 840246
Renton, Washington, United States, 98055
United States, Wisconsin
Investigational Site Number 840311
Milwaukee, Wisconsin, United States, 53209
Bulgaria
Investigational Site Number 100205
Blagoevgrad, Bulgaria, 2700
Investigational Site Number 100203
Byala, Bulgaria, 7100
Investigational Site Number 100204
Plovdiv, Bulgaria, 4002
Investigational Site Number 100201
Plovdiv, Bulgaria, 4002
Investigational Site Number 100206
Sofia, Bulgaria, 1431
Canada
Investigational Site Number 124204
Brampton, Canada, L6R 3J5
Investigational Site Number 124211
Etobicoke, Canada, M9R 4E1
Investigational Site Number 124208
Laval, Canada, H7T 2P5
Investigational Site Number 124214
London, Canada, N6A 5G6
Investigational Site Number 124210
Montreal, Canada, H1Y 3L1
Investigational Site Number 124218
Montreal, Canada, H4N 3C5
Investigational Site Number 124206
Pointe-Claire, Canada, H9R 4S3
Investigational Site Number 124219
Sherbrooke, Canada, J1H 1Z1
Investigational Site Number 124201
Thornhill, Canada, L4J 8L7
Investigational Site Number 124209
Thornhill, Canada, L4J 8L7
Investigational Site Number 124212
Toronto, Canada, M9W 4L9
Investigational Site Number 124216
Ville St-Laurent, Canada, H4T 1Z9
Czech Republic
Investigational Site Number 203205
Brno, Czech Republic, 65691
Investigational Site Number 203201
Brno, Czech Republic, 62500
Investigational Site Number 203204
Havirov, Czech Republic, 73601
Investigational Site Number 203203
Praha 10, Czech Republic, 10034
Investigational Site Number 203202
Praha 8, Czech Republic, 18100
Denmark
Investigational Site Number 208203
Esbjerg, Denmark, 6700
Investigational Site Number 208209
Hellerup, Denmark, 2900
Investigational Site Number 208202
Herlev, Denmark, 2730
Investigational Site Number 208206
Hvidovre, Denmark, 2650
Investigational Site Number 208210
Kolding, Denmark, 6000
Investigational Site Number 208207
København Nv, Denmark, 2400
Investigational Site Number 208201
Odense C, Denmark, 5000
Investigational Site Number 208204
Viborg, Denmark, 8800
Investigational Site Number 208205
Ålborg, Denmark, 9100
Estonia
Investigational Site Number 233204
Tallinn, Estonia, 13419
Investigational Site Number 233205
Tartu, Estonia, 50410
Investigational Site Number 233203
Tartu, Estonia, 50406
Finland
Investigational Site Number 246208
Helsinki, Finland, 260
Investigational Site Number 246202
Kokkola, Finland, 67100
Investigational Site Number 246207
Oulu, Finland, 90100
Investigational Site Number 246206
Tampere, Finland, 33100
Investigational Site Number 246205
Turku, Finland, 20100
Hungary
Investigational Site Number 348205
Balassagyarmat, Hungary, 2660
Investigational Site Number 348207
Budapest, Hungary, 1036
Investigational Site Number 348210
Budapest, Hungary, 1134
Investigational Site Number 348212
Budapest, Hungary, 1083
Investigational Site Number 348201
Budapest, Hungary, 1036
Investigational Site Number 348202
Urhida, Hungary, 8142
Japan
Investigational Site Number 392214
Fujimi, Japan
Investigational Site Number 392215
Fujimi, Japan
Investigational Site Number 392206
Ise-Shi, Japan
Investigational Site Number 392217
Kitaazumi-Gun, Japan
Investigational Site Number 392210
Matsumoto-Shi, Japan
Investigational Site Number 392208
Matumoto, Japan
Investigational Site Number 392205
Midori-Shi, Japan
Investigational Site Number 392203
Mito-Shi, Japan
Investigational Site Number 392216
Sakai, Japan
Investigational Site Number 392213
Shimotsuke, Japan
Investigational Site Number 392218
Shunan-Shi, Japan
Investigational Site Number 392204
Yamagata-Shi, Japan
Latvia
Investigational Site Number 428205
Riga, Latvia, LV-1050
Investigational Site Number 428206
Riga, Latvia, 1024
Investigational Site Number 428203
Riga, Latvia, LV-1002
Investigational Site Number 428202
Sigulda, Latvia, LV-2150
Investigational Site Number 428201
Ventspils, Latvia, LV-3601
Lithuania
Investigational Site Number 440203
Kaunas, Lithuania, 48259
Investigational Site Number 440204
Kaunas, Lithuania, 49449
Investigational Site Number 440201
Klaipeda, Lithuania, 92253
Investigational Site Number 440202
Klaipeda, Lithuania, LT-92304
Investigational Site Number 440205
Vilnius, Lithuania, 08661
Netherlands
Investigational Site Number 528204
Almere, Netherlands, 1311 RL
Investigational Site Number 528209
Beek, Netherlands, 6191 JW
Investigational Site Number 528205
Breda, Netherlands, 4811 SW
Investigational Site Number 528207
Leiderdorp, Netherlands, 2352 RA
Investigational Site Number 528203
Rotterdam, Netherlands, 3021 HC
Investigational Site Number 528202
Velp, Netherlands, 6883 ES
Puerto Rico
Investigational Site Number 840709
Cagua, Puerto Rico, 725
Investigational Site Number 840706
Carolina, Puerto Rico, 987
Investigational Site Number 840701
Carolina, Puerto Rico, 00983
Investigational Site Number 840702
Ponce, Puerto Rico, 07716
Investigational Site Number 840707
Ponce, Puerto Rico, 00717
Investigational Site Number 840708
San Juan, Puerto Rico, 926
Investigational Site Number 840703
San Juan, Puerto Rico, 917
Investigational Site Number 840704
San Juan, Puerto Rico, 00917
Romania
Investigational Site Number 642208
Bacau, Romania, 600164
Investigational Site Number 642201
Bucuresti, Romania, 20475
Investigational Site Number 642212
Bucuresti, Romania, 020359
Investigational Site Number 642202
Cluj-Napoca, Romania, 400006
Investigational Site Number 642213
Oradea, Romania, 410169
Investigational Site Number 642207
Resita, Romania, 320076
Investigational Site Number 642205
Sibiu, Romania, 550371
Investigational Site Number 642204
Targu Mures, Romania, 540142
Investigational Site Number 642203
Targu Mures, Romania, 540142
Investigational Site Number 642209
Timisoara, Romania, 300456
Investigational Site Number 642206
Timisoara, Romania, 300133
Slovakia
Investigational Site Number 703205
Banska Bystrica, Slovakia, 97517
Investigational Site Number 703202
Bardejov, Slovakia, 085 01
Investigational Site Number 703203
Bratislava, Slovakia, 85101
Investigational Site Number 703201
Levice, Slovakia, 93405
Investigational Site Number 703206
Levice, Slovakia, 95401
Investigational Site Number 703207
Lucenec, Slovakia, 98401
Sweden
Investigational Site Number 752205
Kristianstad, Sweden, 29185
Investigational Site Number 752206
Malmö, Sweden, 211 52
Investigational Site Number 752201
Stockholm, Sweden, 11522
Investigational Site Number 752204
Vällingby, Sweden, 16268
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01676220     History of Changes
Other Study ID Numbers: EFC12347, 2012-000146-35, U1111-1124-5261
Study First Received: August 28, 2012
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014