Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
- Registration Number
- NCT01960179
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan
Secondary Objective:
To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:
* HbA1c (Glycated hemoglobin A1c) reduction;
* Fasting plasma glucose;
* Body weight.
- Detailed Description
* Group 1: 60 weeks ± 11 days
* Group 2: 32 weeks ± 7 days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 361
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lixisenatide lixisenatide AVE0010 lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment)
- Primary Outcome Measures
Name Time Method Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data. from baseline to 24 weeks and 52 weeks
- Secondary Outcome Measures
Name Time Method Absolute change in HbA1c from baseline to week 24 and week 52 Absolute change in body weight from baseline to week 24 and week 52 Absolute change in fasting plasma glucose from baseline to week 24 and week 52
Trial Locations
- Locations (30)
Investigational Site Number 392006
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392005
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392010
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392004
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392015
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392003
🇯🇵Chuoh-Ku, Japan
Investigational Site Number 392012
🇯🇵Ebina-Shi, Japan
Investigational Site Number 392024
🇯🇵Higashiosaka-Shi, Japan
Investigational Site Number 392023
🇯🇵Kashiwara-Shi, Japan
Investigational Site Number 392008
🇯🇵Kawagoe-Shi, Japan
Scroll for more (20 remaining)Investigational Site Number 392006🇯🇵Adachi-Ku, Japan