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

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01768559

Run by

Sanofi

People needed

894

Starts

2013-01-01

Expected to finish

2014-12-01

Last updated by the study team

2017-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840042 — Tempe, Arizona, United States
• Investigational Site Number 840003 — Little Rock, Arkansas, United States
• Investigational Site Number 840031 — La Mesa, California, United States
• Investigational Site Number 840005 — Mission Viejo, California, United States
• Investigational Site Number 840057 — Northridge, California, United States
• Investigational Site Number 840035 — Santa Ana, California, United States
• Investigational Site Number 840002 — Temecula, California, United States
• Investigational Site Number 840037 — Walnut Creek, California, United States
• Investigational Site Number 840023 — West Hills, California, United States
• Investigational Site Number 840041 — Denver, Colorado, United States
• Investigational Site Number 840012 — Miami, Florida, United States
• Investigational Site Number 840061 — Miami, Florida, United States
• Investigational Site Number 840045 — Lawrenceville, Georgia, United States
• Investigational Site Number 840036 — Nampa, Idaho, United States
• Investigational Site Number 840024 — Chicago, Illinois, United States
• Investigational Site Number 840009 — Evanston, Illinois, United States
• Investigational Site Number 840004 — Avon, Indiana, United States
• Investigational Site Number 840055 — Avon, Indiana, United States
• Investigational Site Number 840027 — Des Moines, Iowa, United States
• Investigational Site Number 840006 — Wichita, Kansas, United States
• Investigational Site Number 840047 — Lexington, Kentucky, United States
• Investigational Site Number 840056 — Paducah, Kentucky, United States
• Investigational Site Number 840022 — Marrero, Louisiana, United States
• Investigational Site Number 840016 — Baltimore, Maryland, United States
• Investigational Site Number 840043 — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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