Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Primary Objective:

 To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in
 particular, the effects on plasma changes in triglycerides.

 Secondary Objectives:

 The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48;
 free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL)
 oxidation.

 The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent
 diabetes mellitus (NIDDM) and obesity.

 The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of
 lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.
Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0
 (baseline) plus a 10-week open-label, active-controlled treatment period
 (Final/End-of-treatment Visit).
Inclusion criteria:

 Male and female patients, 18-70 years of age.

 Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30
 kg/m^2) and the following other abnormalities:

 -  Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According
 to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).

 -  Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might
 reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual
 patients, if this can be achieved without significant hypoglycemia or other adverse
 effects of treatment. Appropriate patients might include those with short duration of
 diabetes, long life expectancy, and no significant cardiovascular disease).

 -  Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL,
 cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a
 primitive dyslipidemia).

 -  Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <40 mg/dL in men
 and <50 mg/dL in women).

 Written informed consent.

 Exclusion criteria:

 Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid
 suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of
 hypothyroidism).

 Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2
 times the upper limit of normal).

 Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of
 coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6
 months before enrollment.

 History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg
 and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic
 pancreatitis or of idiopathic acute pancreatitis.

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.