Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Primary Objective:

 To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a
 standardized breakfast from baseline to Day 29.

 Secondary Objectives:

 To demonstrate:

 -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,
 C-peptide and glucagon levels after a standardized breakfast

 -  Delaying gastric emptying (13C-acetic acid breath test)

 -  Safety and tolerability
The duration per patient could be minimum of 38 to 47 days depending on screening visit and
 post-treatment observation allowances.

 13C-acetic acid breath test will be conducted only in investigational site which can be
 implemented (about 40 patients).
Inclusion criteria:

 -  Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis

 -  Aged 20-75 years

 -  Hemoglobin A1C ≥7.0%-≤10.0%

 -  Fasting plasma glucose ≤180 mg/dL at screening

 -  Stable treatment (±20%) with Lantus for 3 months or more prior to screening.

 -  Sulfonylurea dose stable for 3 months or more prior to screening

 Exclusion criteria:

 -  Type 1 diabetes mellitus

 -  Pregnancy or lactation

 -  Hypersensitivity to Lixisenatide

 -  Severely uncontrolled glycemic situation

 -  History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
 stomach/gastric surgery or inflammatory bowel disease

 -  History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to
 screening

 -  History within the previous 6 months of myocardial infarction, stroke or heart failure
 requiring hospitalization or drug or alcohol abuse

 -  Uncontrolled/inadequately controlled hypertension at the time of screening, with a
 resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg

 -  Amylase and/or lipase >3 times or aspartate aminotransferase (AST), alanine
 aminotransferase (ALT) or alkaline phosphatase (ALP) >2 times the upper limit of the
 normal laboratory range

 -  End-stage renal disease and/or dialysis and clinically relevant history of
 gastrointestinal disease

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