Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Completed · Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: * The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Secondary Objectives: * To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on: * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test; * Percentage of participants reaching HbA1c \<7% or ≤6.5%; * 7-point Self-Monitored Plasma Glucose (SMPG) profile; * Body weight; * Insulin glargine dose * Fasting Plasma Glucose (FPG); * Percentage of participants requiring rescue therapy during the 24-week open label treatment period; * To assess safety and tolerability of insulin glargine/lixisenatide FRC.

Key facts

Study ID

NCT01476475

Run by

Sanofi

People needed

323

Starts

2011-11-01

Expected to finish

2012-12-01

Last updated by the study team

2017-02-10

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

You may not qualify if…

• Age < legal age of adulthood (18 years).
• Screening HbA1c <7% or >10%.
• Screening FPG >250 mg/dL (>13.9 mmol/L).
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
• Type 1 diabetes mellitus.
• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
• Use of insulin within the last 6 months.
• Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
• Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN) at screening.
• Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
• Alanine Transferase (ALT) >3 ULN 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).
• Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively.
• Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
• Body Mass Index (BMI) ≤20 or >40 kg/m\^2.
• Any previous treatment with lixisenatide
• 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 840412 — Paramount, California, United States
• Investigational Site Number 840401 — Larenceville, Georgia, United States
• Investigational Site Number 840417 — Roswell, Georgia, United States
• Investigational Site Number 840403 — Lexington, Kentucky, United States
• Investigational Site Number 840404 — Hyattsville, Maryland, United States
• Investigational Site Number 840405 — Rockville, Maryland, United States
• Investigational Site Number 840411 — Las Vegas, Nevada, United States
• Investigational Site Number 840415 — West Seneca, New York, United States
• Investigational Site Number 840402 — Norman, Oklahoma, United States
• Investigational Site Number 840407 — Medford, Oregon, United States
• Investigational Site Number 840413 — Durham, Pennsylvania, United States
• Investigational Site Number 840410 — Dallas, Texas, United States
• Investigational Site Number 840414 — Renton, Washington, United States
• Investigational Site Number 152404 — Santiago, Chile
• Investigational Site Number 152405 — Santiago, Chile
• Investigational Site Number 152403 — Santiago, Chile
• Investigational Site Number 152401 — Santiago, Chile
• Investigational Site Number 152402 — Santiago, Chile
• Investigational Site Number 203403 — Nový Jičín, Czechia
• Investigational Site Number 203401 — Pilsen, Czechia
• Investigational Site Number 203402 — Prague, Czechia
• Investigational Site Number 203405 — Prague, Czechia
• Investigational Site Number 208401 — København NV, Denmark
• Investigational Site Number 208404 — Køge, Denmark
• Investigational Site Number 840408 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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