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

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