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

NCT02941367 · Completed

Last updated 2026-05-28

This clinical trial tested the safety of adding Lyxumia (lixisenatide) or a sulfonylurea to basal insulin in adults with uncontrolled type 2 diabetes who chose to fast during Ramadan.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 184 people

Who can join Ages 18+ · all sexes

Timeline Started 2017-02 · est. completion 2017-08

Where 16 sites · India, Israel, Kuwait, Turkey (Türkiye)

What this study is testing ClinicalTrials.gov NCT02941367 ↗

Description as written by the study sponsor.

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.

Treatments tested

Lixisenatide (AVE0010) also known as Lyxumia Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
Sulfonylurea Drug

Pharmaceutical form: tablet Route of administration: oral
metformin Drug

Pharmaceutical form: tablet Route of administration: oral
basal insulin Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Main thing measured	Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Sponsor	Sanofi
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02941367 ↗