Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

• To compare the treatments/regimens on:

• The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,

• Body weight,

• Self-Monitored Glucose profiles,

• Fasting Plasma Glucose (FPG),

• Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),

• Daily doses of insulins,

• Safety and tolerability.

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

Details

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

Criteria

Inclusion criteria :

• Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).

• Participants treated with basal insulin for at least 6 months.

• Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.

• Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

• At screening: age < legal age of majority.

• At screening, HbA1c: <7.5% and >10.0% for participants treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.

• Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.

• Type 1 diabetes mellitus.

• Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.

• Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.

• Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.

• At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2.

• Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.

• Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

• At screening resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.

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

• Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.

• Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.

• At screening, amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN).

• At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.

• At screening calcitonin ≥20 pg/ml (5.9 pmol/L).

Exclusion Criteria for randomization at the end of the screening period before randomization:

• HbA1c <7.0% or >9.0%.

• 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).

• Amylase and/or lipase >3 times ULN.

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