Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: lixisenatide AVE0010; Drug: TZD; Drug: biguanide; Drug: alpha-GI; Drug: glinide

• Registration Number: NCT01940965
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.

Secondary Objective:

To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:

* HbA1c;

* Fasting plasma glucose;

* Body weight.

Detailed Description

54 weeks +/-11 days

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lixisenatide + TZD	lixisenatide AVE0010	52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Lixisenatide + TZD	TZD	52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Lixisenatide + Biguanide	lixisenatide AVE0010	52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Lixisenatide + Biguanide	biguanide	52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Lixisenatide + alpha-GI	alpha-GI	52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Lixisenatide + Glinide	glinide	52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
Lixisenatide + alpha-GI	lixisenatide AVE0010	52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Lixisenatide + Glinide	lixisenatide AVE0010	52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)

Primary Outcome Measures

Name	Time	Method
Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data	52 weeks

Secondary Outcome Measures

Name	Time	Method
Absolute change in HbA1c	From baseline to weeks 24 and 52
Absolute change in fasting plasma glucose	From baseline to weeks 24 and 52
Absolute change in body weight	From baseline to weeks 24 and 52

Trial Locations

Locations (27)

Investigational Site Number 392335; 🇯🇵 Adachi-Ku, Japan

Investigational Site Number 392325; 🇯🇵 Chiba-Shi, Japan

Investigational Site Number 392328; 🇯🇵 Chiyoda-Ku, Japan

Investigational Site Number 392326; 🇯🇵 Chuo-Ku, Japan

Investigational Site Number 392327; 🇯🇵 Chuo-Ku, Japan

Investigational Site Number 392310; 🇯🇵 Chuoh-Ku, Japan

Investigational Site Number 392336; 🇯🇵 Kagoshima-Shi, Japan

Investigational Site Number 392314; 🇯🇵 Kamakura-Shi, Japan

Investigational Site Number 392334; 🇯🇵 Kashiwara-Shi, Japan

Investigational Site Number 392304; 🇯🇵 Kawagoe-Shi, Japan

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