A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Sanofi51 sites in 4 countries447 target enrollmentOctober 2012

ConditionsType 2 Diabetes Mellitus

InterventionsLixisenatide (AVE0010)Placebo

DrugsLixisenatide (AVE0010)Placebo

Overview

Phase: Phase 3
Intervention: Lixisenatide (AVE0010)
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Enrollment: 447
Locations: 51
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary Objective:

To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

To assess the effects of lixisenatide over 24 weeks on :
- percentage of patients reaching HbA1c<7% or ≤6.5%,
- 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
- fasting plasma glucose (FPG),
- change in 7-point self-monitored plasma glucose (SMPG) profile),
- body weight,
- change in daily basal insulin dose.
To assess lixisenatide safety and tolerability.
To assess anti-lixisenatide antibody development.

Detailed Description

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Lixisenatide

24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Intervention: Lixisenatide (AVE0010)

Placebo

24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Intervention: Placebo

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: from baseline to week 24

Secondary Outcomes

Percentage of patients with HbA1c <7%, =<6.5%(at week 24)
Change in 2-hour postprandial plasma glucose and plasma glucose excursion(from baseline to week 24)
Change in fasting plasma glucose(from baseline to week 24)
Change in 7-point self monitoring plasma glucose profile (average and each point)(from baseline to week 24)
Change in body weight(from baseline to week 24)
Change in daily basal insulin dose(from baseline to week 24)
Number of patients with adverse events(24 weeks)
Anti-lixisenatide antibody assessment(from baseline to week 24)