Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

Sponsor
Sanofi
Study ID
NCT01596504
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lixisenatide (AVE0010) — DRUG
    Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®). Route of administration: subcutaneous
  • Liraglutide — DRUG
    Pharmaceutical form:solution for injection Route of administration: subcutaneous
  • Insulin Glargine — DRUG
    Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL)
  • Metformin — DRUG
    If previously taken metformin to be continued at stable dose throughout the study

Study Details

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).

Key Dates

Start date
May 31, 2012
Status verified
Aug 2016
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
142 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lixisenatide 20 μg
    Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks under fasted conditions, on top of insulin glargine with or without metformin.
  • Active Comparator: Liraglutide 1.2 mg
    Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks under fasted conditions, on top of insulin glargine with or without metformin.
  • Active Comparator: Liraglutide 1.8 mg
    Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks under fasted conditions, on top of insulin glargine with or without metformin.

Primary Outcome Measure

Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours [ Time Frame: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56 ]

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