Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 294
Not provided
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 392328
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392335
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392310
🇯🇵Chuoh-Ku, Japan
Investigational Site Number 392329
🇯🇵Ohta-Ku, Japan
Investigational Site Number 392326
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392336
🇯🇵Kagoshima-Shi, Japan
Investigational Site Number 392312
🇯🇵Mitaka-Shi, Japan
Investigational Site Number 392314
🇯🇵Kamakura-Shi, Japan
Investigational Site Number 392303
🇯🇵Sakado-Shi, Japan
Investigational Site Number 392319
🇯🇵Suita-Shi, Japan
Investigational Site Number 392327
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392325
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392306
🇯🇵Kawaguchi-Shi, Japan
Investigational Site Number 392301
🇯🇵Koriyama-Shi, Japan
Investigational Site Number 392304
🇯🇵Kawagoe-Shi, Japan
Investigational Site Number 392334
🇯🇵Kashiwara-Shi, Japan
Investigational Site Number 392322
🇯🇵Okawa-Shi, Japan
Investigational Site Number 392331
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392302
🇯🇵Mito-Shi, Japan
Investigational Site Number 392332
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392333
🇯🇵Osaka-Shi, Japan
Investigational Site Number 392320
🇯🇵Saijo-Shi, Japan
Investigational Site Number 392311
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 392316
🇯🇵Shizuoka-Shi, Japan
Investigational Site Number 392324
🇯🇵Mito-Shi, Japan
Investigational Site Number 392330
🇯🇵Sagamihara-Shi, Japan
Investigational Site Number 392307
🇯🇵Kisarazu-Shi, Japan