NCT02752412

Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.

Detailed description

The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine/Lixisenatide (HOE901/AVE0010)	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Insulin glargine U100 (HOE901)	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Metformin	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2016-05-17
• Primary completion: 2018-10-04
• Completion: 2018-10-04
• First posted: 2016-04-27
• Last updated: 2020-06-16

Locations

122 sites across 1 country: Japan