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

sites

Clinical Trial Facility in Fargo North Dakota

Fargo, North Dakota 58103

from

Fargo, ND