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

NCT01768559

CompletedPhase 3

Sponsor: Sanofi

Conditions: Type 2 Diabetes

Interventions: Lixisenatide (AVE0010), Insulin glulisine QD, Insulin glulisine TID, Insulin Glargine (Mandatory background drug), Metformin (Background drug)

Countries: United States, Canada, Chile, Czechia, Estonia, France, Germany, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (199)

Sun City, Arizona, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
La Mesa, California, United States
Mission Viejo, California, United States
Northridge, California, United States
Santa Ana, California, United States
Temecula, California, United States
Walnut Creek, California, United States
West Hills, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Miami, Florida, United States
Lawrenceville, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Avon, Indiana, United States
Avon, Indiana, United States
Des Moines, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Paducah, Kentucky, United States
Marrero, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Buckley, Michigan, United States
Dearborn, Michigan, United States
Kalamazoo, Michigan, United States
Las Vegas, Nevada, United States
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