Comparison of lixisenatide injected prior to the main meal of the day versus prior to breakfast in type 2 diabetic patients on metformi
- Conditions
- Type II Diabetes MellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-002416-85-CZ
- Lead Sponsor
- sanofi-aventis Recherche et Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
• Patients 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
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
- Patients who usually do not eat breakfast
- Type 1 diabetes mellitus
- Body Mass Index (BMI) = 20 kg/m² and > 40 kg/ m²
- 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
- ALT> 3ULN 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24);Secondary Objective: To assess the effect of the 2 lixisenatide regimens on:<br>• The percentage of patients who reached the target of HbA1c < 7% or = 6.5% at week 24<br>• Fasting Plasma Glucose (FPG)<br>• 7-point Self-Monitored Plasma Glucose (SMPG) profiles<br>• Body weight <br>To assess the safety and tolerability of the 2 lixisenatide regimens<br>;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Percentage of patients reaching HbA1c <7 % <br>- Percentage of patients reaching HbA1c =6.5 %<br>- Change in 7-point self-monitored plasma glucose profile<br>- Change in Fasting plasma glucose<br>- Change in Body weight;Timepoint(s) of evaluation of this end point: 24 weeks