NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: Insulin glargine /lixisenatide Fixed Ratio Combination, Insulin glargine, Metformin (Background drug)
Countries: United States, Chile, Czechia, Denmark, France, Germany, Hungary, Lithuania
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * 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. Exclusion criteria: * 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.
- Little Rock, Arkansas, United States
- Paramount, California, United States
- Larenceville, Georgia, United States
- Roswell, Georgia, United States
- Lexington, Kentucky, United States
- Hyattsville, Maryland, United States
- Rockville, Maryland, United States
- Las Vegas, Nevada, United States
- West Seneca, New York, United States
- Norman, Oklahoma, United States
- Medford, Oregon, United States
- Durham, Pennsylvania, United States
- Dallas, Texas, United States
- Renton, Washington, United States
- Santiago, Chile
- Santiago, Chile
- Santiago, Chile
- Santiago, Chile
- Santiago, Chile
- Nový Jičín, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Prague, Czechia
- København NV, Denmark
- Køge, Denmark
- Slagelse, Denmark
- Svendborg, Denmark
- Narbonne, France
- Poitiers, France
- Vandœuvre-lès-Nancy, France
- + 40 more on CT.gov