Trials / Completed
CompletedNCT03798080
Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin
A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 426 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin. Secondary Objectives: * To assess the effects of iGlarLixi in comparison with insulin glargine * To assess the safety in each treatment group
Detailed description
The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), 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 | Metformin | Pharmaceutical form: tablet Route of administration: oral |
Timeline
- Start date
- 2019-02-19
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2019-01-09
- Last updated
- 2022-07-19
Locations
45 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03798080. Inclusion in this directory is not an endorsement.