Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: HOE901-U300 (new formulation of insulin glargine)
- Registration Number
- NCT01676220
- Lead Sponsor
- Sanofi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 878
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOE901-U300 HOE901-U300 (new formulation of insulin glargine) - Lantus Lantus (insulin glargine) -
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Month 6 Endpoint Baseline, Month 6 Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HbA1c <7% at Month 6 Month 6 Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint Baseline, Month 6 Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Variability of Preinjection SMPG at Month 6 Endpoint Month 6 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.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint Baseline, Month 6 Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6 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.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Up to 12 months 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).
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Week 9 Up to Month 6 Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Baseline, Month 6 Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint Baseline, Month 6 Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint Baseline, Month 6 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.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Baseline, Month 6 Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint Baseline, Month 6 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.
Trial Locations
- Locations (217)
Investigational Site Number 840297
🇺🇸Torrance, California, United States
Investigational Site Number 840232
🇺🇸Overland Park, Kansas, United States
Investigational Site Number 840248
🇺🇸Hollywood, Florida, United States
Investigational Site Number 840292
🇺🇸Dallas, Texas, United States
Investigational Site Number 840217
🇺🇸Mesa, Arizona, United States
Investigational Site Number 840299
🇺🇸Boca Raton, Florida, United States
Investigational Site Number 840289
🇺🇸Fall River, Massachusetts, United States
Investigational Site Number 840247
🇺🇸Asheville, North Carolina, United States
Investigational Site Number 840307
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840324
🇺🇸Montgomery, Alabama, United States
Investigational Site Number 840246
🇺🇸Renton, Washington, United States
Investigational Site Number 840296
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 840237
🇺🇸Spartanburg, South Carolina, United States
Investigational Site Number 840315
🇺🇸Dallas, Texas, United States
Investigational Site Number 840242
🇺🇸Dallas, Texas, United States
Investigational Site Number 840342
🇺🇸Corpus Christi, Texas, United States
Investigational Site Number 840269
🇺🇸Albuquerque, New Mexico, United States
Investigational Site Number 840203
🇺🇸Sea Girt, New Jersey, United States
Investigational Site Number 840229
🇺🇸Norman, Oklahoma, United States
Investigational Site Number 840295
🇺🇸Sicklerville, New Jersey, United States
Investigational Site Number 840275
🇺🇸Morganton, North Carolina, United States
Investigational Site Number 752201
🇸🇪Stockholm, Sweden
Investigational Site Number 203201
🇨🇿Brno, Czech Republic
Investigational Site Number 208202
🇩🇰Herlev, Denmark
Investigational Site Number 124212
🇨🇦Toronto, Canada
Investigational Site Number 840310
🇺🇸New Hyde Park, New York, United States
Investigational Site Number 840219
🇺🇸Bend, Oregon, United States
Investigational Site Number 233205
🇪🇪Tartu, Estonia
Investigational Site Number 124211
🇨🇦Etobicoke, Canada
Investigational Site Number 124214
🇨🇦London, Canada
Investigational Site Number 124206
🇨🇦Pointe-Claire, Canada
Investigational Site Number 124208
🇨🇦Laval, Canada
Investigational Site Number 124210
🇨🇦Montreal, Canada
Investigational Site Number 124216
🇨🇦Ville St-Laurent, Canada
Investigational Site Number 203202
🇨🇿Praha 8, Czech Republic
Investigational Site Number 392214
🇯🇵Fujimi, Japan
Investigational Site Number 208209
🇩🇰Hellerup, Denmark
Investigational Site Number 752206
🇸🇪Malmö, Sweden
Investigational Site Number 246206
🇫🇮Tampere, Finland
Investigational Site Number 392205
🇯🇵Midori-Shi, Japan
Investigational Site Number 703203
🇸🇰Bratislava, Slovakia
Investigational Site Number 752205
🇸🇪Kristianstad, Sweden
Investigational Site Number 752204
🇸🇪Vällingby, Sweden
Investigational Site Number 840330
🇺🇸Cleveland, Ohio, United States
Investigational Site Number 840338
🇺🇸Houston, Texas, United States
Investigational Site Number 840328
🇺🇸Houston, Texas, United States
Investigational Site Number 840304
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840257
🇺🇸Fresno, California, United States
Investigational Site Number 840347
🇺🇸Bell Gardens, California, United States
Investigational Site Number 840213
🇺🇸Greenbrae, California, United States
Investigational Site Number 840235
🇺🇸La Mesa, California, United States
Investigational Site Number 840222
🇺🇸Long Beach, California, United States
Investigational Site Number 840274
🇺🇸La Mesa, California, United States
Investigational Site Number 840250
🇺🇸Spring Valley, California, United States
Investigational Site Number 840243
🇺🇸Palm Springs, California, United States
Investigational Site Number 840209
🇺🇸Temecula, California, United States
Investigational Site Number 840272
🇺🇸Tustin, California, United States
Investigational Site Number 840249
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840285
🇺🇸Boynton Beach, Florida, United States
Investigational Site Number 840223
🇺🇸Walnut Creek, California, United States
Investigational Site Number 840221
🇺🇸Bradenton, Florida, United States
Investigational Site Number 840233
🇺🇸Clearwater, Florida, United States
Investigational Site Number 840266
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 840204
🇺🇸Hialeah, Florida, United States
Investigational Site Number 840212
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 840337
🇺🇸Miami Beach, Florida, United States
Investigational Site Number 840318
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840226
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840224
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840227
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 840303
🇺🇸North Miami Beach, Florida, United States
Investigational Site Number 840225
🇺🇸Ocala, Florida, United States
Investigational Site Number 840288
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number 840216
🇺🇸Oviedo, Florida, United States
Investigational Site Number 840332
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840325
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 840309
🇺🇸St. Petersburg, Florida, United States
Investigational Site Number 840339
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 840245
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 840323
🇺🇸Stockbridge, Georgia, United States
Investigational Site Number 840278
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840283
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 840320
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840276
🇺🇸Springfield, Illinois, United States
Investigational Site Number 840317
🇺🇸Avon, Indiana, United States
Investigational Site Number 840231
🇺🇸Murray, Kentucky, United States
Investigational Site Number 840314
🇺🇸Avon, Indiana, United States
Investigational Site Number 840208
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840301
🇺🇸Rockville, Maryland, United States
Investigational Site Number 840270
🇺🇸Madison Heights, Michigan, United States
Investigational Site Number 840262
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 840294
🇺🇸Dakota Dunes, South Dakota, United States
Investigational Site Number 840268
🇺🇸Dallas, Texas, United States
Investigational Site Number 840327
🇺🇸Pearland, Texas, United States
Investigational Site Number 840202
🇺🇸Murray, Utah, United States
Investigational Site Number 124204
🇨🇦Brampton, Canada
Investigational Site Number 124218
🇨🇦Montreal, Canada
Investigational Site Number 124201
🇨🇦Thornhill, Canada
Investigational Site Number 840228
🇺🇸Miami, Florida, United States
Investigational Site Number 840238
🇺🇸Miami, Florida, United States
Investigational Site Number 840302
🇺🇸Miami, Florida, United States
Investigational Site Number 840287
🇺🇸Topeka, Kansas, United States
Investigational Site Number 840207
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840282
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840343
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 208203
🇩🇰Esbjerg, Denmark
Investigational Site Number 208206
🇩🇰Hvidovre, Denmark
Investigational Site Number 208210
🇩🇰Kolding, Denmark
Investigational Site Number 208207
🇩🇰København Nv, Denmark
Investigational Site Number 208201
🇩🇰Odense C, Denmark
Investigational Site Number 208204
🇩🇰Viborg, Denmark
Investigational Site Number 208205
🇩🇰Ålborg, Denmark
Investigational Site Number 840273
🇺🇸Chandler, Arizona, United States
Investigational Site Number 840306
🇺🇸Hamilton, New Jersey, United States
Investigational Site Number 840348
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 100201
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 840234
🇺🇸Tempe, Arizona, United States
Investigational Site Number 840211
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840220
🇺🇸Peoria, Arizona, United States
Investigational Site Number 840253
🇺🇸Haverhill, Massachusetts, United States
Investigational Site Number 840264
🇺🇸Tempe, Arizona, United States
Investigational Site Number 840349
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 100206
🇧🇬Sofia, Bulgaria
Investigational Site Number 233204
🇪🇪Tallinn, Estonia
Investigational Site Number 348202
🇭🇺Urhida, Hungary
Investigational Site Number 392206
🇯🇵Ise-Shi, Japan
Investigational Site Number 392210
🇯🇵Matsumoto-Shi, Japan
Investigational Site Number 392203
🇯🇵Mito-Shi, Japan
Investigational Site Number 440201
🇱🇹Klaipeda, Lithuania
Investigational Site Number 440202
🇱🇹Klaipeda, Lithuania
Investigational Site Number 528204
🇳🇱Almere, Netherlands
Investigational Site Number 840706
🇵🇷Carolina, Puerto Rico
Investigational Site Number 840252
🇺🇸Greer, South Carolina, United States
Investigational Site Number 840260
🇺🇸Bristol, Tennessee, United States
Investigational Site Number 348212
🇭🇺Budapest, Hungary
Investigational Site Number 642208
🇷🇴Bacau, Romania
Investigational Site Number 233203
🇪🇪Tartu, Estonia
Investigational Site Number 246207
🇫🇮Oulu, Finland
Investigational Site Number 428206
🇱🇻Riga, Latvia
Investigational Site Number 428203
🇱🇻Riga, Latvia
Investigational Site Number 428205
🇱🇻Riga, Latvia
Investigational Site Number 440203
🇱🇹Kaunas, Lithuania
Investigational Site Number 528205
🇳🇱Breda, Netherlands
Investigational Site Number 528207
🇳🇱Leiderdorp, Netherlands
Investigational Site Number 840709
🇵🇷Cagua, Puerto Rico
Investigational Site Number 840256
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 100204
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 203204
🇨🇿Havirov, Czech Republic
Investigational Site Number 246202
🇫🇮Kokkola, Finland
Investigational Site Number 246205
🇫🇮Turku, Finland
Investigational Site Number 392216
🇯🇵Sakai, Japan
Investigational Site Number 392218
🇯🇵Shunan-Shi, Japan
Investigational Site Number 528209
🇳🇱Beek, Netherlands
Investigational Site Number 840710
🇵🇷San Juan, Puerto Rico
Investigational Site Number 840201
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 100205
🇧🇬Blagoevgrad, Bulgaria
Investigational Site Number 100203
🇧🇬Byala, Bulgaria
Investigational Site Number 203205
🇨🇿Brno, Czech Republic
Investigational Site Number 246208
🇫🇮Helsinki, Finland
Investigational Site Number 348201
🇭🇺Budapest, Hungary
Investigational Site Number 203203
🇨🇿Praha 10, Czech Republic
Investigational Site Number 348205
🇭🇺Balassagyarmat, Hungary
Investigational Site Number 392215
🇯🇵Fujimi, Japan
Investigational Site Number 428202
🇱🇻Sigulda, Latvia
Investigational Site Number 440204
🇱🇹Kaunas, Lithuania
Investigational Site Number 440205
🇱🇹Vilnius, Lithuania
Investigational Site Number 840703
🇵🇷San Juan, Puerto Rico
Investigational Site Number 642212
🇷🇴Bucuresti, Romania
Investigational Site Number 642202
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 642213
🇷🇴Oradea, Romania
Investigational Site Number 642207
🇷🇴Resita, Romania
Investigational Site Number 642209
🇷🇴Timisoara, Romania
Investigational Site Number 348207
🇭🇺Budapest, Hungary
Investigational Site Number 392204
🇯🇵Yamagata-Shi, Japan
Investigational Site Number 348210
🇭🇺Budapest, Hungary
Investigational Site Number 392217
🇯🇵Kitaazumi-Gun, Japan
Investigational Site Number 392208
🇯🇵Matumoto, Japan
Investigational Site Number 392213
🇯🇵Shimotsuke, Japan
Investigational Site Number 428201
🇱🇻Ventspils, Latvia
Investigational Site Number 528203
🇳🇱Rotterdam, Netherlands
Investigational Site Number 840704
🇵🇷San Juan, Puerto Rico
Investigational Site Number 840708
🇵🇷San Juan, Puerto Rico
Investigational Site Number 642205
🇷🇴Sibiu, Romania
Investigational Site Number 703202
🇸🇰Bardejov, Slovakia
Investigational Site Number 703201
🇸🇰Levice, Slovakia
Investigational Site Number 528202
🇳🇱Velp, Netherlands
Investigational Site Number 642201
🇷🇴Bucuresti, Romania
Investigational Site Number 703205
🇸🇰Banska Bystrica, Slovakia
Investigational Site Number 642206
🇷🇴Timisoara, Romania
Investigational Site Number 642203
🇷🇴Targu Mures, Romania
Investigational Site Number 642204
🇷🇴Targu Mures, Romania
Investigational Site Number 703206
🇸🇰Levice, Slovakia
Investigational Site Number 703207
🇸🇰Lucenec, Slovakia
Investigational Site Number 124219
🇨🇦Sherbrooke, Canada
Investigational Site Number 124209
🇨🇦Thornhill, Canada
Investigational Site Number 840331
🇺🇸Denver, Colorado, United States
Investigational Site Number 840251
🇺🇸Tampa, Florida, United States
Investigational Site Number 840300
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840210
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840263
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840311
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number 840240
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840218
🇺🇸Houston, Texas, United States
Investigational Site Number 840259
🇺🇸Houston, Texas, United States
Investigational Site Number 840308
🇺🇸Tipton, Pennsylvania, United States
Investigational Site Number 840206
🇺🇸Manassas, Virginia, United States
Investigational Site Number 840291
🇺🇸Orlando, Florida, United States
Investigational Site Number 840316
🇺🇸Orlando, Florida, United States
Investigational Site Number 840236
🇺🇸Honolulu, Hawaii, United States
Investigational Site Number 840290
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 840344
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 840214
🇺🇸Des Moines, Iowa, United States
Investigational Site Number 840267
🇺🇸Huntington Beach, California, United States
Investigational Site Number 840230
🇺🇸La Jolla, California, United States
Investigational Site Number 840326
🇺🇸Edinburg, Texas, United States
Investigational Site Number 840239
🇺🇸Burke, Virginia, United States
Investigational Site Number 840244
🇺🇸Escondido, California, United States