Type 2 Diabetes Mellitus Clinical Trial
Official title:
An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin
Primary Objective:
- To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg QD (once
daily) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma
glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after
a standardized breakfast at the end of a 8-week treatment period in patients with type 2
diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin)
Secondary Objectives:
- To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8
mg QD after a 8-week treatment period in patients with T2DM not adequately controlled
with insulin glargine (± metformin) on:
- Post-prandial C-peptide, glucagon and appetite perceptions after a standardized
breakfast
- Appetite perceptions after standardized dinner
- Gastric emptying after a standardized labelled test meal
- Fasting plasma glucose, 24-hour plasma glucose profile
- HbA1c
- Insulin glargine dose
- 7-point self monitored plasma glucose (SMPG)
- Body weight and waist circumference
- 24-hour heart rate and blood pressure
- To assess lixisenatide and liraglutide safety and tolerability as add on treatment to
insulin glargine (± metformin)
Up to 2-week Screening period
- A run-in period of 12 week at maximum including a forced titration with insulin
glargine up to 11 weeks and 1 baseline pharmacodynamic assessment week
- A 8-week treatment(s) period(s) up to Day 57
- Follow-up: 7 ±2 days after the last treatment day
- Total study duration approximately 14 weeks up to 23 weeks
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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