Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.

Key facts

Study ID

NCT02058147

Run by

Sanofi

People needed

1170

Starts

2014-02-01

Expected to finish

2015-06-01

Last updated by the study team

2017-05-09

Who can join

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

You may qualify if…

• Participants with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (DPP-4) inhibitors, and who were not adequately controlled with this treatment.
• Signed written informed consent.

You may not qualify if…

• HbA1c at screening visit:
• less than 7.5% or more than 10% for participants previously treated with metformin alone,
• less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment.
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
• Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening.
• Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
• History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
• Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide.
• Any contraindication to metformin use, according to local labeling.
• Use of weight loss drugs within 3 months prior to screening visit.
• Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
• History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).
• Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
• At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m\^2.
• At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
• At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
• At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).
• Exclusion Criteria for randomization at the end of the screening period:
• HbA1c less than 7% or above 10%;
• Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);
• Metformin maximal tolerated dose less than 1500 mg/day;
• Amylase and/or lipase more than 3 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 840122 — Phoenix, Arizona, United States
• Investigational Site Number 840062 — Tempe, Arizona, United States
• Investigational Site Number 840023 — Tempe, Arizona, United States
• Investigational Site Number 840084 — Little Rock, Arkansas, United States
• Investigational Site Number 840100 — Anaheim, California, United States
• Investigational Site Number 840065 — Bell Gardens, California, United States
• Investigational Site Number 840090 — Chino, California, United States
• Investigational Site Number 840002 — Chula Vista, California, United States
• Investigational Site Number 840013 — Concord, California, United States
• Investigational Site Number 840053 — Fresno, California, United States
• Investigational Site Number 840017 — La Jolla, California, United States
• Investigational Site Number 840070 — Lancaster, California, United States
• Investigational Site Number 840121 — Long Beach, California, United States
• Investigational Site Number 840126 — Los Angeles, California, United States
• Investigational Site Number 840044 — Los Angeles, California, United States
• Investigational Site Number 840101 — Mission Hills, California, United States
• Investigational Site Number 840086 — Mission Viejo, California, United States
• Investigational Site Number 840120 — Mission Viejo, California, United States
• Investigational Site Number 840005 — Northridge, California, United States
• Investigational Site Number 840034 — Palm Springs, California, United States
• Investigational Site Number 840074 — Port Hueneme, California, United States
• Investigational Site Number 840068 — San Ramon, California, United States
• Investigational Site Number 840067 — Santa Ana, California, United States
• Investigational Site Number 840029 — Tarzana, California, United States
• Investigational Site Number 840027 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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