Trials / Completed
CompletedNCT03798054
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Antidiabetic Drug(s)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 878 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin glargine/Lixisenatide (HOE901/AVE0010) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Insulin glargine (HOE901) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Lixisenatide (AVE0010) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Metformin | Pharmaceutical form: tablet Route of administration: oral |
| DRUG | SGLT2 inhibitor | Pharmaceutical form:tablet Route of administration: oral |
Timeline
- Start date
- 2019-02-15
- Primary completion
- 2021-03-01
- Completion
- 2021-03-01
- First posted
- 2019-01-09
- Last updated
- 2022-07-19
Locations
79 sites across 4 countries: China, Malaysia, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT03798054. Inclusion in this directory is not an endorsement.