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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Lixisenatide; Sitagliptin Phosphate

Criteria

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