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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2017-08-04
Completion
2017-08-04

Countries

  • India
  • Israel
  • Kuwait
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02941367 on ClinicalTrials.gov