A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: HOE901-U300 (Insulin Glargine 300 U/ml)Drug: Mandated back ground therapy
- Registration Number
- NCT02688933
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.
Secondary Objective:
To demonstrate that treatment with HOE901-U300 compared to Lantus provides:
* Lower incidence rate of nocturnal symptomatic hypoglycemia;
* Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
* Less variability in CGM profile.
- Detailed Description
The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 638
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOE901-U300 Mandated back ground therapy HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia. Lantus Mandated back ground therapy Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia. HOE901-U300 HOE901-U300 (Insulin Glargine 300 U/ml) HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia. Lantus Lantus (Insulin Glargine 100 U/ml) Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.
- Primary Outcome Measures
Name Time Method Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM During Week 15 and/or 16 The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia Baseline up to Week 16 Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).
Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection During Week 15 and/or Week 16 Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).
Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year Baseline up to Week 16 Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.
Coefficient of Variation (CV%) in Mean CGM Glucose During Week 15 and/or Week 16 CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.
Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16 Baseline, during Week 15 and/or Week 16 Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).
Trial Locations
- Locations (100)
Investigational Site Number 840-044
🇺🇸Los Angeles, California, United States
Investigational Site Number 840-040
🇺🇸Henderson, Nevada, United States
Investigational Site Number 840-019
🇺🇸Dallas, Texas, United States
Investigational Site Number 840-075
🇺🇸Dallas, Texas, United States
Investigational Site Number 840-056
🇺🇸Burlington, Vermont, United States
Investigational Site Number 840-004
🇺🇸Fresno, California, United States
Investigational Site Number 840-149
🇺🇸Escondido, California, United States
Investigational Site Number 840-071
🇺🇸Concord, California, United States
Investigational Site Number 840-124
🇺🇸La Jolla, California, United States
Investigational Site Number 840-110
🇺🇸Greenbrae, California, United States
Investigational Site Number 840-030
🇺🇸La Mesa, California, United States
Investigational Site Number 840-129
🇺🇸Los Gatos, California, United States
Investigational Site Number 840-022
🇺🇸Los Angeles, California, United States
Investigational Site Number 840-090
🇺🇸Pomona, California, United States
Investigational Site Number 840-069
🇺🇸Pomona, California, United States
Investigational Site Number 840-024
🇺🇸Northridge, California, United States
Investigational Site Number 840-132
🇺🇸Rolling Hills Estates, California, United States
Investigational Site Number 840-055
🇺🇸San Ramon, California, United States
Investigational Site Number 840-130
🇺🇸San Jose, California, United States
Investigational Site Number 840-028
🇺🇸Santa Barbara, California, United States
Investigational Site Number 840-063
🇺🇸Tarzana, California, United States
Investigational Site Number 840-016
🇺🇸Ventura, California, United States
Investigational Site Number 840-138
🇺🇸Tustin, California, United States
Investigational Site Number 840-133
🇺🇸Hialeah, Florida, United States
Investigational Site Number 840-046
🇺🇸Englewood, Colorado, United States
Investigational Site Number 840-072
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 840-137
🇺🇸Maitland, Florida, United States
Investigational Site Number 840-023
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 840-053
🇺🇸Ocoee, Florida, United States
Investigational Site Number 840-112
🇺🇸Ormond Beach, Florida, United States
Investigational Site Number 840-047
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 840-018
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840-036
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 840-001
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 840-064
🇺🇸Columbus, Georgia, United States
Investigational Site Number 840-008
🇺🇸Roswell, Georgia, United States
Investigational Site Number 840-014
🇺🇸Stockbridge, Georgia, United States
Investigational Site Number 840-125
🇺🇸Arlington Heights, Illinois, United States
Investigational Site Number 840-134
🇺🇸Crystal Lake, Illinois, United States
Investigational Site Number 840-011
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840-073
🇺🇸Wichita, Kansas, United States
Investigational Site Number 840-002
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 840-062
🇺🇸Covington, Kentucky, United States
Investigational Site Number 840-054
🇺🇸Hyattsville, Maryland, United States
Investigational Site Number 840-122
🇺🇸Waltham, Massachusetts, United States
Investigational Site Number 840-006
🇺🇸Rockville, Maryland, United States
Investigational Site Number 840-157
🇺🇸Framingham, Massachusetts, United States
Investigational Site Number 840-037
🇺🇸Flint, Michigan, United States
Investigational Site Number 840-067
🇺🇸Billings, Montana, United States
Investigational Site Number 840-094
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 840-109
🇺🇸Staten Island, New York, United States
Investigational Site Number 840-102
🇺🇸New York, New York, United States
Investigational Site Number 840-108
🇺🇸New York, New York, United States
Investigational Site Number 840-010
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 840-080
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 840-045
🇺🇸Greenville, North Carolina, United States
Investigational Site Number 840-051
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 840-123
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840-079
🇺🇸Norman, Oklahoma, United States
Investigational Site Number 840-104
🇺🇸Mentor, Ohio, United States
Investigational Site Number 840-162
🇺🇸Bend, Oregon, United States
Investigational Site Number 840-003
🇺🇸Dallas, Texas, United States
Investigational Site Number 840-005
🇺🇸Dallas, Texas, United States
Investigational Site Number 840-153
🇺🇸El Paso, Texas, United States
Investigational Site Number 840-013
🇺🇸Dallas, Texas, United States
Investigational Site Number 840-026
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 840-140
🇺🇸Lufkin, Texas, United States
Investigational Site Number 840-029
🇺🇸Mesquite, Texas, United States
Investigational Site Number 840-150
🇺🇸Pearland, Texas, United States
Investigational Site Number 840-048
🇺🇸North Richland Hills, Texas, United States
Investigational Site Number 840-083
🇺🇸Murray, Utah, United States
Investigational Site Number 840-101
🇺🇸Ogden, Utah, United States
Investigational Site Number 840-143
🇺🇸Bennington, Vermont, United States
Investigational Site Number 840-015
🇺🇸Renton, Washington, United States
Investigational Site Number 840-139
🇺🇸Bridgeport, West Virginia, United States
Investigational Site Number 840-074
🇺🇸Spokane, Washington, United States
Investigational Site Number 840-081
🇺🇸Houston, Texas, United States
Investigational Site Number 840-160
🇺🇸Houston, Texas, United States
Investigational Site Number 840-156
🇺🇸Houston, Texas, United States
Investigational Site Number 840-152
🇺🇸Houston, Texas, United States
Investigational Site Number 840-031
🇺🇸Houston, Texas, United States
Investigational Site Number 840-049
🇺🇸Miami, Florida, United States
Investigational Site Number 840-076
🇺🇸Miami, Florida, United States
Investigational Site Number 840-017
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840-097
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 840-060
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 840-058
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 840-009
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 840-111
🇵🇷Manati, Puerto Rico
Investigational Site Number 840-039
🇺🇸Denver, Colorado, United States
Investigational Site Number 840-021
🇺🇸Denver, Colorado, United States
Investigational Site Number 840-070
🇺🇸Denver, Colorado, United States
Investigational Site Number 840-114
🇺🇸Tampa, Florida, United States
Investigational Site Number 840-042
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 840-032
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 840-033
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840-142
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840-096
🇺🇸Portland, Oregon, United States
Investigational Site Number 840-151
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840-012
🇺🇸Lawrenceville, Georgia, United States