Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Lixisenatide (AVE0010); Drug: Placebo

• Registration Number: NCT01632163
• Lead Sponsor: Sanofi

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)

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-02
• Study Start: 2012-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lixisenatide	Lixisenatide (AVE0010)	24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Placebo	Placebo	24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Change in body weight	from baseline to week 24
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 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

Trial Locations

Locations (51)

Investigational Site Number 156001; 🇨🇳 Beijing, China

Investigational Site Number 156033; 🇨🇳 Beijing, China

Investigational Site Number 156006; 🇨🇳 Beijing, China

Investigational Site Number 156005; 🇨🇳 Beijing, China

Investigational Site Number 156004; 🇨🇳 Beijing, China

Investigational Site Number 156002; 🇨🇳 Beijing, China

Investigational Site Number 156016; 🇨🇳 Changchun, China

Investigational Site Number 156025; 🇨🇳 Changsha, China

Investigational Site Number 156014; 🇨🇳 Chengdu, China

Investigational Site Number 156013; 🇨🇳 Chengdu, China

Scroll for more (41 remaining)