Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24 * Fasting Plasma Glucose (FPG) * 7-point Self-Monitored Plasma Glucose (SMPG) profiles * Body weight * To assess the safety and tolerability of the 2 lixisenatide regimens

Key facts

Study ID

NCT01517412

Run by

Sanofi

People needed

451

Starts

2012-02-01

Expected to finish

2013-05-01

Last updated by the study team

2016-10-14

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

You may not qualify if…

• Screening HbA1c < 7.0% and > 10.0%
• Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)
• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
• Participants who usually did not eat breakfast
• Type 1 diabetes mellitus
• Body Mass Index (BMI) ≤ 20 kg/m\^2 and > 40 kg/m\^2
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
• Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening
• Alanine aminotransferase (ALT) > 3 ULN at screening
• Calcitonin ≧ 20 pg/ml (5.9 pmol/L) 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)
• Any contra-indication related to metformin
• Any previous treatment with lixisenatide
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840113 — Mesa, Arizona, United States
• Investigational Site Number 840105 — Phoenix, Arizona, United States
• Investigational Site Number 840102 — Tempe, Arizona, United States
• Investigational Site Number 840107 — Tempe, Arizona, United States
• Investigational Site Number 840116 — Mission Viejo, California, United States
• Investigational Site Number 840103 — Northridge, California, United States
• Investigational Site Number 840118 — Redlands, California, United States
• Investigational Site Number 840104 — Temecula, California, United States
• Investigational Site Number 840122 — Chicago, Illinois, United States
• Investigational Site Number 840119 — Chicago, Illinois, United States
• Investigational Site Number 840114 — Springfield, Illinois, United States
• Investigational Site Number 840120 — Flint, Michigan, United States
• Investigational Site Number 840115 — Billings, Montana, United States
• Investigational Site Number 840101 — Sea Girt, New Jersey, United States
• Investigational Site Number 840111 — Fargo, North Dakota, United States
• Investigational Site Number 840110 — West Jordan, Utah, United States
• Investigational Site Number 124102 — Brampton, Canada
• Investigational Site Number 124108 — Coquitlam, Canada
• Investigational Site Number 124106 — Etobicoke, Canada
• Investigational Site Number 124113 — Kelowna, Canada
• Investigational Site Number 124110 — Laval, Canada
• Investigational Site Number 124103 — Newmarket, Canada
• Investigational Site Number 124101 — Oakville, Canada
• Investigational Site Number 124111 — Saint Romuald, Canada
• Investigational Site Number 840112 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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