NCT02787551

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

Detailed description

The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period. Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period. All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine/lixisenatide fixed ratio combination	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	liraglutide	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	exenatide	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	exenatide extended-release	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	albiglutide	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	dulaglutide	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)	Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.

Timeline

• Start date: 2016-07-06
• Primary completion: 2018-05-25
• Completion: 2018-11-17
• First posted: 2016-06-01
• Last updated: 2022-03-25
• Results posted: 2019-06-12

Locations

124 sites across 9 countries: United States, Canada, Estonia, Germany, Israel, Italy, Romania, Slovakia, Spain