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

• Status: Completed
• Trial end date: 2017-08-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin, Globin Zinc; Lixisenatide; Metformin

Criteria

Inclusion criteria :

• Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug.

• Patients who express the intention to fast during Ramadan.

• Signed informed consent.

Exclusion criteria:

• At the time of screening age < legal age of majority.

• Glycated hemoglobin (HbA1c) at screening visit: <7.5% or >10%.

• Body mass index (BMI) <20kg/m^2.

• Treatment with basal insulin for less than 6 months prior to screening.

• Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and <20% dose change) in the last 8 weeks prior to screening.

• Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening.

• Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.

• Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided.

• Type 1, gestational or secondary diabetes.

• History of diabetic ketoacidosis.

• History of hypoglycemia unawareness.

• Any medical contraindication for sustained and safe fasting.

• Pregnant or breast-feeding women.

• Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

• Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients.

• All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.