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More info
You can access this
clinical trial
if you have
Type 2 Diabetes Mellitus
and you are
between 18 and 75
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

Primary Objective: - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) 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 participants 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 an 8-week treatment period in participants 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, - Glycosylated hemoglobin (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).

Provided treatments

  • Drug: Lixisenatide (AVE0010)
  • Drug: Liraglutide
  • Drug: Insulin Glargine
  • Drug: Metformin

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01596504. The sponsor of the trial is Sanofi and it is looking for 142 volunteers for the current phase.
Official trial 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