NCT02941367

Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU). Secondary Objectives: * To assess effect of lixisenatide versus SU on: * Changes in glycemic control; * Changes in body weight. * To assess overall safety of lixisenatide and SU.

Detailed description

The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Lixisenatide (AVE0010)	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	Sulfonylurea	Pharmaceutical form: tablet Route of administration: oral
DRUG	metformin	Pharmaceutical form: tablet Route of administration: oral
DRUG	basal insulin	Pharmaceutical form: solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2017-02-23
• Primary completion: 2017-08-04
• Completion: 2017-08-04
• First posted: 2016-10-21
• Last updated: 2022-04-25

Locations

16 sites across 4 countries: India, Israel, Kuwait, Turkey (Türkiye)