Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | January 2012 |
| End Date: | June 2013 |
| Contact: | For site information, send an email with site number to |
| Email: | Contact-Us@sanofi.com |
A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin
Primary 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:
- The percentage of patients 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
The maximum study duration will be 28 weeks per patient, including a 24-week randomized
treatment period.
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
16
sites
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