Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

• To assess the effect of the 2 lixisenatide regimens on:

• The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24

• Fasting Plasma Glucose (FPG)

• 7-point Self-Monitored Plasma Glucose (SMPG) profiles

• Body weight

• To assess the safety and tolerability of the 2 lixisenatide regimens

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Lixisenatide; Metformin

Criteria

Inclusion criteria:

• Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit

• Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Exclusion criteria:

• Screening HbA1c < 7.0% and > 10.0%

• Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)

• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin

• Participants who usually did not eat breakfast

• Type 1 diabetes mellitus

• Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2

• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method

• Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening

• Alanine aminotransferase (ALT) > 3 ULN at screening

• Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.

• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)

• Any contra-indication related to metformin

• Any previous treatment with lixisenatide

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