Status:
COMPLETED
Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief 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:...
Detailed Description
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 investigationa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT02200991
Start Date
August 1 2014
End Date
November 1 2015
Last Update
October 5 2016
Active Locations (20)
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1
Investigational Site Number 392-107
Atsugi-shi, Japan
2
Investigational Site Number 392-125
Chiyoda-ku, Japan
3
Investigational Site Number 392-121
Chuoh-ku, Japan
4
Investigational Site Number 392-102
Ichihara-shi, Japan