Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: HOE901-U300 (Insulin glargine new formulation)
- Registration Number
- NCT01683266
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus
Secondary Objective:
* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
* Change of HbA1c from baseline to endpoint (scheduled Month 6)
* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
- Detailed Description
The maximum study duration was up to approximately 54 weeks per participants:
* Up to 2-week screening period
* 6-month open-label comparative efficacy and safety treatment period
* 6-month open-label comparative safety extension period
* 48-hour post-treatment safety follow-up period
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 549
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOE901-U300 HOE901-U300 (Insulin glargine new formulation) HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or 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 \[mg/dL\]). Lantus Lantus (Insulin glargine) Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or 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).
- Primary Outcome Measures
Name Time Method Change In HbA1c From Baseline to Month 6 Endpoint Baseline, Month 6
- Secondary Outcome Measures
Name Time Method Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint 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.
Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint Month 6 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.
Change in Variability of Pre-injection 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. 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.
Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6 Month 6 Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint Baseline, Month 6 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.
Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint Baseline, Month 6 Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint Baseline, Month 6 Percentage of Participants With HbA1c <7% at Month 6 Endpoint Month 6 Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 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).
Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint Month 6
Trial Locations
- Locations (147)
Investigational Site Number 203103
🇨🇿Praha 8, Czech Republic
Investigational Site Number 124109
🇨🇦Montreal, Canada
Investigational Site Number 233104
🇪🇪Pärnu, Estonia
Investigational Site Number 124101
🇨🇦Toronto, Canada
Investigational Site Number 203102
🇨🇿Brno, Czech Republic
Investigational Site Number 348107
🇭🇺Budapest, Hungary
Investigational Site Number 124105
🇨🇦Thornhill, Canada
Investigational Site Number 208103
🇩🇰Esbjerg, Denmark
Investigational Site Number 348108
🇭🇺Budapest, Hungary
Investigational Site Number 392104
🇯🇵Karatsu-Shi, Japan
Investigational Site Number 203104
🇨🇿Praha 10, Czech Republic
Investigational Site Number 752104
🇸🇪Vällingby, Sweden
Investigational Site Number 233106
🇪🇪Tartu, Estonia
Investigational Site Number 233101
🇪🇪Tartu, Estonia
Investigational Site Number 752105
🇸🇪Kristianstad, Sweden
Investigational Site Number 752101
🇸🇪Stockholm, Sweden
Investigational Site Number 840177
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840407
🇺🇸Iowa City, Iowa, United States
Investigational Site Number 840117
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 840178
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840172
🇺🇸Avon, Indiana, United States
Investigational Site Number 840191
🇺🇸New Hyde Park, New York, United States
Investigational Site Number 124110
🇨🇦Coquitlam, Canada
Investigational Site Number 840110
🇺🇸Oviedo, Florida, United States
Investigational Site Number 840116
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840184
🇺🇸St Louis, Missouri, United States
Investigational Site Number 840170
🇺🇸Topeka, Kansas, United States
Investigational Site Number 840180
🇺🇸Rockville, Maryland, United States
Investigational Site Number 124104
🇨🇦Laval, Canada
Investigational Site Number 233103
🇪🇪Viljandimaa, Estonia
Investigational Site Number 840162
🇺🇸Springfield, Illinois, United States
Investigational Site Number 840171
🇺🇸St Louis Park, Minnesota, United States
Investigational Site Number 840101
🇺🇸Murray, Utah, United States
Investigational Site Number 124108
🇨🇦Mirabel, Canada
Investigational Site Number 246106
🇫🇮Loimaa, Finland
Investigational Site Number 246103
🇫🇮Tampere, Finland
Investigational Site Number 840112
🇺🇸Bend, Oregon, United States
Investigational Site Number 840125
🇺🇸Burke, Virginia, United States
Investigational Site Number 840140
🇺🇸Fresno, California, United States
Investigational Site Number 840119
🇺🇸Norman, Oklahoma, United States
Investigational Site Number 840134
🇺🇸Hollywood, Florida, United States
Investigational Site Number 840420
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 840195
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 840173
🇺🇸Syracuse, New York, United States
Investigational Site Number 840167
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 840104
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840150
🇺🇸Dallas, Texas, United States
Investigational Site Number 840412
🇺🇸Dallas, Texas, United States
Investigational Site Number 840130
🇺🇸Houston, Texas, United States
Investigational Site Number 840141
🇺🇸Houston, Texas, United States
Investigational Site Number 840156
🇺🇸Chandler, Arizona, United States
Investigational Site Number 840430
🇺🇸Bell Gardens, California, United States
Investigational Site Number 840131
🇺🇸Escondido, California, United States
Investigational Site Number 840107
🇺🇸Greenbrae, California, United States
Investigational Site Number 840120
🇺🇸La Jolla, California, United States
Investigational Site Number 840149
🇺🇸Huntington Beach, California, United States
Investigational Site Number 840114
🇺🇸Long Beach, California, United States
Investigational Site Number 840159
🇺🇸La Mesa, California, United States
Investigational Site Number 840115
🇺🇸Walnut Creek, California, United States
Investigational Site Number 840155
🇺🇸Tustin, California, United States
Investigational Site Number 840189
🇺🇸Mission Hills, California, United States
Investigational Site Number 840105
🇺🇸Temecula, California, United States
Investigational Site Number 840113
🇺🇸Bradenton, Florida, United States
Investigational Site Number 840102
🇺🇸Hialeah, Florida, United States
Investigational Site Number 840185
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840163
🇺🇸Nampa, Idaho, United States
Investigational Site Number 840133
🇺🇸Asheville, North Carolina, United States
Investigational Site Number 840169
🇺🇸Mentor, Ohio, United States
Investigational Site Number 840402
🇺🇸Spokane, Washington, United States
Investigational Site Number 840103
🇺🇸Manassas, Virginia, United States
Investigational Site Number 840126
🇺🇸Miami, Florida, United States
Investigational Site Number 840179
🇺🇸Miami, Florida, United States
Investigational Site Number 840197
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number 840139
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840166
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840187
🇺🇸Nashville, Tennessee, United States
Investigational Site Number 208105
🇩🇰Gentofte, Denmark
Investigational Site Number 208104
🇩🇰København Nv, Denmark
Investigational Site Number 208107
🇩🇰Køge, Denmark
Investigational Site Number 208102
🇩🇰Ålborg, Denmark
Investigational Site Number 752103
🇸🇪Goteborg, Sweden
Investigational Site Number 840160
🇺🇸Denver, Colorado, United States
Investigational Site Number 840188
🇺🇸Denver, Colorado, United States
Investigational Site Number 840181
🇺🇸Tampa, Florida, United States
Investigational Site Number 840106
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840411
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number 840145
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 428102
🇱🇻Sigulda, Latvia
Investigational Site Number 528105
🇳🇱Nijmegen, Netherlands
Investigational Site Number 642107
🇷🇴Bacau, Romania
Investigational Site Number 840123
🇺🇸La Mesa, California, United States
Investigational Site Number 840137
🇺🇸Haverhill, Massachusetts, United States
Investigational Site Number 840153
🇺🇸Madison Heights, Michigan, United States
Investigational Site Number 840161
🇺🇸Morganton, North Carolina, United States
Investigational Site Number 840127
🇺🇸Tacoma, Washington, United States
Investigational Site Number 840403
🇺🇸Seattle, Washington, United States
Investigational Site Number 840427
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 840408
🇺🇸Detroit, Michigan, United States
Investigational Site Number 840132
🇺🇸Renton, Washington, United States
Investigational Site Number 642104
🇷🇴Sibiu, Romania
Investigational Site Number 348102
🇭🇺Gyula, Hungary
Investigational Site Number 392105
🇯🇵Ise-Shi, Japan
Investigational Site Number 392111
🇯🇵Kitakyushu-Shi, Japan
Investigational Site Number 392112
🇯🇵Matsumoto-Shi, Japan
Investigational Site Number 428106
🇱🇻Limbazi, Latvia
Investigational Site Number 348101
🇭🇺Urhida, Hungary
Investigational Site Number 840144
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 392110
🇯🇵Aisai-Shi, Japan
Investigational Site Number 392108
🇯🇵Matumoto, Japan
Investigational Site Number 392103
🇯🇵Midori-Shi, Japan
Investigational Site Number 528102
🇳🇱Zwijndrecht, Netherlands
Investigational Site Number 642109
🇷🇴Oradea, Romania
Investigational Site Number 642105
🇷🇴Timisoara, Romania
Investigational Site Number 392106
🇯🇵Yamagata-Shi, Japan
Investigational Site Number 428105
🇱🇻Riga, Latvia
Investigational Site Number 246102
🇫🇮Kokkola, Finland
Investigational Site Number 246105
🇫🇮Oulu, Finland
Investigational Site Number 428103
🇱🇻Riga, Latvia
Investigational Site Number 840426
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 246101
🇫🇮Kuopio, Finland
Investigational Site Number 348106
🇭🇺Debrecen, Hungary
Investigational Site Number 392107
🇯🇵Mito-Shi, Japan
Investigational Site Number 392101
🇯🇵Sakai-Shi, Japan
Investigational Site Number 392102
🇯🇵Tomishiro, Japan
Investigational Site Number 528103
🇳🇱Beek, Netherlands
Investigational Site Number 840602
🇵🇷Ponce, Puerto Rico
Investigational Site Number 642106
🇷🇴Resita, Romania
Investigational Site Number 840136
🇺🇸Greer, South Carolina, United States
Investigational Site Number 233105
🇪🇪Tallinn, Estonia
Investigational Site Number 428101
🇱🇻Ventspils, Latvia
Investigational Site Number 528101
🇳🇱Almere, Netherlands
Investigational Site Number 528104
🇳🇱Venlo, Netherlands
Investigational Site Number 642103
🇷🇴Brasov, Romania
Investigational Site Number 642101
🇷🇴Targu Mures, Romania
Investigational Site Number 642102
🇷🇴Targu Mures, Romania
Investigational Site Number 642108
🇷🇴Timisoara, Romania
Investigational Site Number 840122
🇺🇸Dakota Dunes, South Dakota, United States
Investigational Site Number 348103
🇭🇺Budapest, Hungary
Investigational Site Number 840196
🇺🇸New Haven, Connecticut, United States
Investigational Site Number 840174
🇺🇸Orlando, Florida, United States
Investigational Site Number 840175
🇺🇸Chapel Hill, North Carolina, United States
Investigational Site Number 840124
🇺🇸Honolulu, Hawaii, United States
Investigational Site Number 840108
🇺🇸Des Moines, Iowa, United States
Investigational Site Number 840421
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 840151
🇺🇸Albuquerque, New Mexico, United States
Investigational Site Number 840109
🇺🇸Austin, Texas, United States
Investigational Site Number 840157
🇺🇸Austin, Texas, United States