Clinical trial NCT01676220: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in HbA1c From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6
timeFrame: Week 9 Up to Month 6
measure: Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Variability of Preinjection SMPG at Month 6 Endpoint
timeFrame: Month 6
measure: Percentage of Participants With HbA1c <7% at Month 6
timeFrame: Month 6
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6
timeFrame: Month 6
measure: Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Daily Basal Insulin Dose From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Investigational Site Number 840324
state: Alabama
city: Chandler
country: United States
facility: Investigational Site Number 840273
state: Arizona
city: Mesa
country: United States
facility: Investigational Site Number 840217
state: Arizona
city: Peoria
country: United States
facility: Investigational Site Number 840220
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840211
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840207
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840264
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840234
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840304
state: Arkansas
city: Bell Gardens
country: United States
facility: Investigational Site Number 840347
state: California
city: Escondido
country: United States
facility: Investigational Site Number 840244
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840257
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 840213
state: California
city: Huntington Beach
country: United States
facility: Investigational Site Number 840267
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840230
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840235
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840274
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840222
state: California
city: Palm Springs
country: United States
facility: Investigational Site Number 840243
state: California
city: Spring Valley
country: United States
facility: Investigational Site Number 840250
state: California
city: Temecula
country: United States
facility: Investigational Site Number 840209
state: California
city: Torrance
country: United States
facility: Investigational Site Number 840297
state: California
city: Tustin
country: United States
facility: Investigational Site Number 840272
state: California
city: Walnut Creek
country: United States
facility: Investigational Site Number 840223
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840249
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840331
state: Colorado
city: Boca Raton
country: United States
facility: Investigational Site Number 840299
state: Florida
city: Boynton Beach
country: United States
facility: Investigational Site Number 840285
state: Florida
city: Bradenton
country: United States
facility: Investigational Site Number 840221
state: Florida
city: Clearwater
country: United States
facility: Investigational Site Number 840233
state: Florida
city: Coral Gables
country: United States
facility: Investigational Site Number 840212
state: Florida
city: Coral Gables
country: United States
facility: Investigational Site Number 840266
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 840204
state: Florida
city: Hollywood
country: United States
facility: Investigational Site Number 840248
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840226
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840318
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840224
state: Florida
city: Miami Beach
country: United States
facility: Investigational Site Number 840337
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840228
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840238
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840302
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840227
state: Florida
city: North Miami Beach
country: United States
facility: Investigational Site Number 840303
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840225
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840291
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840316
state: Florida
city: Oviedo
country: United States
facility: Investigational Site Number 840216
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840332
state: Florida
city: Pembroke Pines
country: United States
facility: Investigational Site Number 840288
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 840325
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site Number 840309
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840251
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site Number 840339
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840245
state: Georgia
city: Stockbridge
country: United States
facility: Investigational Site Number 840323
state: Georgia
city: Honolulu
country: United States
facility: Investigational Site Number 840236
state: Hawaii
city: Idaho Falls
country: United States
facility: Investigational Site Number 840283
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840278
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840320
state: Illinois
city: Springfield
country: United States
facility: Investigational Site Number 840276
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840314
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840317
state: Indiana
city: Des Moines
country: United States
facility: Investigational Site Number 840214
state: Iowa
city: Overland Park
country: United States
facility: Investigational Site Number 840232
state: Kansas
city: Topeka
country: United States
facility: Investigational Site Number 840287
state: Kansas
city: Lexington
country: United States
facility: Investigational Site Number 840344
state: Kentucky
city: Murray
country: United States
facility: Investigational Site Number 840231
state: Kentucky
city: Metairie
country: United States
facility: Investigational Site Number 840348
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site Number 840290
state: Louisiana
city: Baltimore
country: United States
facility: Investigational Site Number 840208
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840301
state: Maryland
city: Fall River
country: United States
facility: Investigational Site Number 840289
state: Massachusetts
city: Haverhill
country: United States
facility: Investigational Site Number 840253
state: Massachusetts
city: Madison Heights
country: United States
facility: Investigational Site Number 840270
state: Michigan
city: Omaha
country: United States
facility: Investigational Site Number 840300
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840210
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840263
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational Site Number 840349
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840201
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840256
state: Nevada
city: Hamilton
country: United States
facility: Investigational Site Number 840306
state: New Jersey
city: Sea Girt
country: United States
facility: Investigational Site Number 840203
state: New Jersey
city: Sicklerville
country: United States
facility: Investigational Site Number 840295
state: New Jersey
city: Albuquerque
country: United States
facility: Investigational Site Number 840269
state: New Mexico
city: New Hyde Park
country: United States
facility: Investigational Site Number 840310
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840247
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840296
state: North Carolina
city: Morganton
country: United States
facility: Investigational Site Number 840275
state: North Carolina
city: Cleveland
country: United States
facility: Investigational Site Number 840330
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840307
state: Ohio
city: Norman
country: United States
facility: Investigational Site Number 840229
state: Oklahoma
city: Bend
country: United States
facility: Investigational Site Number 840219
state: Oregon
city: Philadelphia
country: United States
facility: Investigational Site Number 840240
state: Pennsylvania
city: Tipton
country: United States
facility: Investigational Site Number 840308
state: Pennsylvania
city: Greer
country: United States
facility: Investigational Site Number 840252
state: South Carolina
city: Spartanburg
country: United States
facility: Investigational Site Number 840237
state: South Carolina
city: Dakota Dunes
country: United States
facility: Investigational Site Number 840294
state: South Dakota
city: Bristol
country: United States
facility: Investigational Site Number 840260
state: Tennessee
city: Chattanooga
country: United States
facility: Investigational Site Number 840262
state: Tennessee
city: Corpus Christi
country: United States
facility: Investigational Site Number 840342
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840268
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840292
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840315
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840242
state: Texas
city: Edinburg
country: United States
facility: Investigational Site Number 840326
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840338
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840218
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840328
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840259
state: Texas
city: Pearland
country: United States
facility: Investigational Site Number 840327
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840282
state: Texas
city: Murray
country: United States
facility: Investigational Site Number 840202
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840343
state: Utah
city: Burke
country: United States
facility: Investigational Site Number 840239
state: Virginia
city: Manassas
country: United States
facility: Investigational Site Number 840206
state: Virginia
city: Renton
country: United States
facility: Investigational Site Number 840246
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840311
state: Wisconsin
city: Blagoevgrad
country: Bulgaria
facility: Investigational Site Number 100205
city: Byala
country: Bulgaria
facility: Investigational Site Number 100203
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 100201
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 100204
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100206
city: Brampton
country: Canada
facility: Investigational Site Number 124204
city: Etobicoke
country: Canada
facility: Investigational Site Number 124211
city: Laval
country: Canada
facility: Investigational Site Number 124208
city: London
country: Canada
facility: Investigational Site Number 124214
city: Montreal
country: Canada
facility: Investigational Site Number 124210
city: Montreal
country: Canada
facility: Investigational Site Number 124218
city: Pointe-Claire
country: Canada
facility: Investigational Site Number 124206
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124219
city: Thornhill
country: Canada
facility: Investigational Site Number 124201
city: Thornhill
country: Canada
facility: Investigational Site Number 124209
city: Toronto
country: Canada
facility: Investigational Site Number 124212
city: Ville St-Laurent
country: Canada
facility: Investigational Site Number 124216
city: Brno
country: Czech Republic
facility: Investigational Site Number 203201
city: Brno
country: Czech Republic
facility: Investigational Site Number 203205
city: Havirov
country: Czech Republic
facility: Investigational Site Number 203204
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203203
city: Praha 8
country: Czech Republic
facility: Investigational Site Number 203202
city: Esbjerg
country: Denmark
facility: Investigational Site Number 208203
city: Hellerup
country: Denmark
facility: Investigational Site Number 208209
city: Herlev
country: Denmark
facility: Investigational Site Number 208202
city: Hvidovre
country: Denmark
facility: Investigational Site Number 208206
city: Kolding
country: Denmark
facility: Investigational Site Number 208210
city: København Nv
country: Denmark
facility: Investigational Site Number 208207
city: Odense C
country: Denmark
facility: Investigational Site Number 208201
city: Viborg
country: Denmark
facility: Investigational Site Number 208204
city: Ålborg
country: Denmark
facility: Investigational Site Number 208205
city: Tallinn
country: Estonia
facility: Investigational Site Number 233204
city: Tartu
country: Estonia
facility: Investigational Site Number 233203
city: Tartu
country: Estonia
facility: Investigational Site Number 233205
city: Helsinki
country: Finland
facility: Investigational Site Number 246208
city: Kokkola
country: Finland
facility: Investigational Site Number 246202
city: Oulu
country: Finland
facility: Investigational Site Number 246207
city: Tampere
country: Finland
facility: Investigational Site Number 246206
city: Turku
country: Finland
facility: Investigational Site Number 246205
city: Balassagyarmat
country: Hungary
facility: Investigational Site Number 348205
city: Budapest
country: Hungary
facility: Investigational Site Number 348201
city: Budapest
country: Hungary
facility: Investigational Site Number 348207
city: Budapest
country: Hungary
facility: Investigational Site Number 348212
city: Budapest
country: Hungary
facility: Investigational Site Number 348210
city: Urhida
country: Hungary
facility: Investigational Site Number 348202
city: Fujimi
country: Japan
facility: Investigational Site Number 392214
city: Fujimi
country: Japan
facility: Investigational Site Number 392215
city: Ise-Shi
country: Japan
facility: Investigational Site Number 392206
city: Kitaazumi-Gun
country: Japan
facility: Investigational Site Number 392217
city: Matsumoto-Shi
country: Japan
facility: Investigational Site Number 392210
city: Matumoto
country: Japan
facility: Investigational Site Number 392208
city: Midori-Shi
country: Japan
facility: Investigational Site Number 392205
city: Mito-Shi
country: Japan
facility: Investigational Site Number 392203
city: Sakai
country: Japan
facility: Investigational Site Number 392216
city: Shimotsuke
country: Japan
facility: Investigational Site Number 392213
city: Shunan-Shi
country: Japan
facility: Investigational Site Number 392218
city: Yamagata-Shi
country: Japan
facility: Investigational Site Number 392204
city: Riga
country: Latvia
facility: Investigational Site Number 428206
city: Riga
country: Latvia
facility: Investigational Site Number 428203
city: Riga
country: Latvia
facility: Investigational Site Number 428205
city: Sigulda
country: Latvia
facility: Investigational Site Number 428202
city: Ventspils
country: Latvia
facility: Investigational Site Number 428201
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440203
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440204
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440201
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440202
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440205
city: Almere
country: Netherlands
facility: Investigational Site Number 528204
city: Beek
country: Netherlands
facility: Investigational Site Number 528209
city: Breda
country: Netherlands
facility: Investigational Site Number 528205
city: Leiderdorp
country: Netherlands
facility: Investigational Site Number 528207
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528203
city: Velp
country: Netherlands
facility: Investigational Site Number 528202
city: Cagua
country: Puerto Rico
facility: Investigational Site Number 840709
city: Carolina
country: Puerto Rico
facility: Investigational Site Number 840706
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 840704
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 840710
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 840703
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 840708
city: Bacau
country: Romania
facility: Investigational Site Number 642208
city: Bucuresti
country: Romania
facility: Investigational Site Number 642212
city: Bucuresti
country: Romania
facility: Investigational Site Number 642201
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642202
city: Oradea
country: Romania
facility: Investigational Site Number 642213
city: Resita
country: Romania
facility: Investigational Site Number 642207
city: Sibiu
country: Romania
facility: Investigational Site Number 642205
city: Targu Mures
country: Romania
facility: Investigational Site Number 642203
city: Targu Mures
country: Romania
facility: Investigational Site Number 642204
city: Timisoara
country: Romania
facility: Investigational Site Number 642206
city: Timisoara
country: Romania
facility: Investigational Site Number 642209
city: Banska Bystrica
country: Slovakia
facility: Investigational Site Number 703205
city: Bardejov
country: Slovakia
facility: Investigational Site Number 703202
city: Bratislava
country: Slovakia
facility: Investigational Site Number 703203
city: Levice
country: Slovakia
facility: Investigational Site Number 703201
city: Levice
country: Slovakia
facility: Investigational Site Number 703206
city: Lucenec
country: Slovakia
facility: Investigational Site Number 703207
city: Kristianstad
country: Sweden
facility: Investigational Site Number 752205
city: Malmö
country: Sweden
facility: Investigational Site Number 752206
city: Stockholm
country: Sweden
facility: Investigational Site Number 752201
city: Vällingby
country: Sweden
facility: Investigational Site Number 752204
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.