Trials / Completed
CompletedNCT03767543
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)
A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 265 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
Timeline
- Start date
- 2019-03-11
- Primary completion
- 2020-10-23
- Completion
- 2020-10-23
- First posted
- 2018-12-06
- Last updated
- 2022-04-25
Locations
32 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03767543. Inclusion in this directory is not an endorsement.