Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
- Registration Number
- NCT03767543
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling.
Secondary Objective:
To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).
- Detailed Description
The maximum duration of study per patient is approximately 29 weeks including a 2-week screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment safety follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iGlarlixi WEEKLY INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached iGlarlixi DAILY INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
- Primary Outcome Measures
Name Time Method Change in glycated hemoglobin (HbA1c)% Baseline to Week 26 Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)
- Secondary Outcome Measures
Name Time Method Change in FPG from baseline to Week 26 Baseline to Week 26 Change in FPG from baseline to Week 26
Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26 Baseline to Week 26 Composite endpoint expressed as percentage of patients A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L)
Insulin glargine dose At Week 26 Insulin glargine dose (expressed in units)
Percentage of patients requiring rescue therapy Baseline to Week 26 Percentage of patients requiring rescue therapy during the 26-week open-label treatment period
Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks Baseline to Week 26 Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year
Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks Baseline to Week 26 Percentage of patients experiencing at least 1 hypoglycemia episode defined as \<3.0 mmol/L
Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12 Baseline to Week 12 Change in fasting SMPG from baseline to Week 12
Change in fasting plasma glucose (FPG) from baseline to Week 12 Baseline to Week 12 Change in FPG from baseline to Week 12
Change in 7-point SMPG profile from baseline to Week 26 Baseline to Week 26 Change in 7-point SMPG profile from baseline to Week 26
Change in body weight from baseline to Week 26 Baseline to Week 26 Change in body weight (kg)
Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks Baseline to Week 26 Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L
Change in fasting SMPG from baseline to Week 26 Baseline to Week 26 Change in fasting SMPG from baseline to Week 26
Change in 7-point SMPG profile from baseline to Week 12 Baseline to Week 12 Change in 7-point SMPG profile from baseline to Week 12
Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks Baseline to Week 26 Mean number of hypoglycemia episodes (\<3.0 mmol/L) per patient year of exposure over 1 year
Percentage of patients achieving HbA1c ≤7% at Week 26 At Week 26 Percentage of patients achieving A1c ≤7%
Trial Locations
- Locations (32)
Investigational Site Number 1240004
🇨🇦Barrie, Canada
Investigational Site Number 1240006
🇨🇦Brampton, Canada
Investigational Site Number 1240002
🇨🇦Brampton, Canada
Investigational Site Number 1240005
🇨🇦Burlington, Canada
Investigational Site Number 1240003
🇨🇦Calgary, Canada
Investigational Site Number 1240024
🇨🇦Chicoutimi, Canada
Investigational Site Number 1240014
🇨🇦Concord, Canada
Investigational Site Number 1240017
🇨🇦Etobicoke, Canada
Investigational Site Number 1240030
🇨🇦Greenfield Park, Canada
Investigational Site Number 1240031
🇨🇦Halifax, Canada
Scroll for more (22 remaining)Investigational Site Number 1240004🇨🇦Barrie, Canada