Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 447
Not provided
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 156035
🇨🇳Fuzhou, China
Investigational Site Number 156017
🇨🇳Harbin, China
Investigational Site Number 156028
🇨🇳Shanghai, China
Investigational Site Number 156033
🇨🇳Beijing, China
Investigational Site Number 156006
🇨🇳Beijing, China
Investigational Site Number 156001
🇨🇳Beijing, China
Investigational Site Number 156023
🇨🇳Haikou, China
Investigational Site Number 156016
🇨🇳Changchun, China
Investigational Site Number 156029
🇨🇳Jinan, China
Investigational Site Number 156008
🇨🇳Tianjin, China
Investigational Site Number 156027
🇨🇳Wuhan, China
Investigational Site Number 156009
🇨🇳Shijiazhuang, China
Investigational Site Number 356018
🇮🇳Aligarh, India
Investigational Site Number 356008
🇮🇳Pune, India
Investigational Site Number 356019
🇮🇳Ahmedabad, India
Investigational Site Number 356015
🇮🇳Nagpur, India
Investigational Site Number 356021
🇮🇳Secunderabad, India
Investigational Site Number 643007
🇷🇺Kirov, Russian Federation
Investigational Site Number 643003
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643004
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 356017
🇮🇳Bhubaneswar, India
Investigational Site Number 356002
🇮🇳Hyderabad, India
Investigational Site Number 356024
🇮🇳Hyderabad, India
Investigational Site Number 356026
🇮🇳Bangalore, India
Investigational Site Number 356023
🇮🇳Visakhapatnam, India
Investigational Site Number 643006
🇷🇺Samara, Russian Federation
Investigational Site Number 643005
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 410007
🇰🇷Goyang, Korea, Republic of
Investigational Site Number 410002
🇰🇷Wonju, Korea, Republic of
Investigational Site Number 410006
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 156013
🇨🇳Chengdu, China
Investigational Site Number 156021
🇨🇳Guangzhou, China
Investigational Site Number 156026
🇨🇳Jinan, China
Investigational Site Number 156025
🇨🇳Changsha, China
Investigational Site Number 156014
🇨🇳Chengdu, China
Investigational Site Number 156034
🇨🇳Dalian, China
Investigational Site Number 156005
🇨🇳Beijing, China
Investigational Site Number 156004
🇨🇳Beijing, China
Investigational Site Number 156002
🇨🇳Beijing, China
Investigational Site Number 156018
🇨🇳Qingdao, China
Investigational Site Number 156032
🇨🇳Shenyang, China
Investigational Site Number 156007
🇨🇳Shanghai, China
Investigational Site Number 156036
🇨🇳Siping, China
Investigational Site Number 156010
🇨🇳Suzhou, China
Investigational Site Number 156011
🇨🇳Xi'An, China
Investigational Site Number 156012
🇨🇳Xi'An, China
Investigational Site Number 410001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410003
🇰🇷Daegu, Korea, Republic of
Investigational Site Number 410005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 156019
🇨🇳Nanjing, China
Investigational Site Number 156020
🇨🇳Nanjing, China