Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)Drug: Insulin glargine (HOE901)Drug: SGLT2 inhibitor
- Registration Number
- NCT03798054
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
The co-primary objective of this study is:
* To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
* To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.
Secondary Objectives:
* To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.
* To assess the safety in each treatment group.
- Detailed Description
The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-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 Lyxumia (lixisenatide) Lixisenatide (AVE0010) Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Soliqua (insulin glargine/lixisenatide) SGLT2 inhibitor iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Soliqua (insulin glargine/lixisenatide) Insulin glargine/Lixisenatide (HOE901/AVE0010) iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Lantus (insulin glargine) SGLT2 inhibitor Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Lyxumia (lixisenatide) SGLT2 inhibitor Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Lantus (insulin glargine) Insulin glargine (HOE901) Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Soliqua (insulin glargine/lixisenatide) Metformin iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Lantus (insulin glargine) Metformin Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Lyxumia (lixisenatide) Metformin Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 24 Change in glycated hemoglobin (HbA1c) from baseline to Week 24
- Secondary Outcome Measures
Name Time Method Patients with HbA1c <7.0% At Week 24 Percentage of patients reaching HbA1c \<7% at Week 24
Change in postprandial plasma glucose (PPG) From Baseline to Week 24 Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 24 (for all patients in iGlarLixi or insulin glargine group and patients who receive morning injection in the lixisenatide group)
Change in fasting plasma glucose (FPG) From Baseline to Week 24 Absolute change in FPG from baseline to Week 24
Patients with HbA1c ≤ 6.5% At Week 24 Percentage of patients reaching HbA1c ≤ 6.5% at Week 24
Change in body weight From Baseline to Week 24 Absolute change in body weight from baseline to Week 24
Adverse events (AEs) From Baseline to Week 24 Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24
Patients with HbA1c <7.0% with no body weight gain At Week 24 Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 24
Confirmed hypoglycemia From Baseline to Week 24 Including severe hypoglycemia and episodes of hypoglycemia documented with PG ≤70 mg/dL (3.9 mmol/L) regardless of symptoms from baseline to Week 24
Change in self-monitored plasma glucose (SMPG) profile From Baseline to Week 24 Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value)
Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia At Week 24 Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 24 and no documented (plasma glucose \[PG\] ≤70 mg/dL \[3.9 mmol/L\]) symptomatic hypoglycemia during the 24 week treatment period
Immunogenicity (antibody variables) From Baseline to Week 24 Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24
Trial Locations
- Locations (79)
Investigational Site Number 1560001
🇨🇳Beijing, China
Investigational Site Number 1560006
🇨🇳Beijing, China
Investigational Site Number 1560049
🇨🇳Beijing, China
Investigational Site Number 1560039
🇨🇳Cangzhou, China
Investigational Site Number 1560009
🇨🇳Changchun, China
Investigational Site Number 1560027
🇨🇳Changchun, China
Investigational Site Number 1560016
🇨🇳Changsha, China
Investigational Site Number 1560053
🇨🇳Chengdu, China
Investigational Site Number 1560056
🇨🇳Chengdu, China
Investigational Site Number 1560010
🇨🇳Chenzhou, China
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