Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01457911
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
* To evaluate the percentage of patients reaching HbA1c \< 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
* To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
* To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
- Detailed Description
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMARYL M (Glimepiride and Metformin hydrochloride combination) Glimepiride and Metformin hydrochloride combination (HOE490) AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal AMARYL (Glimepiride) Glimepiride (HOE490) AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal
- Primary Outcome Measures
Name Time Method Absolute change in HbA1c 20 weeks, from baseline to week 20
- Secondary Outcome Measures
Name Time Method Absolute change in Fasting Plasma Glucose 20 weeks, from baseline to week 20 Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively 20 weeks, at week 20 Number of patients reporting adverse events 20 weeks, from baseline to week 20 Number of patients reporting serious adverse events 20 weeks, from baseline to week 20 Hypoglycemia 20 weeks, from baseline to week 20 Vital signs 20 weeks, from baseline to week 20 Hematology, Serum chemistry and lipids 20 weeks, from baseline to week 20
Trial Locations
- Locations (22)
Investigational Site Number 156023
🇨🇳Jinan, China
Investigational Site Number 156021
🇨🇳Shenyang, China
Investigational Site Number 156024
🇨🇳Tianjin, China
Investigational Site Number 156015
🇨🇳Xiamen, China
Investigational Site Number 156016
🇨🇳Beijing, China
Investigational Site Number 156003
🇨🇳Beijing, China
Investigational Site Number 156001
🇨🇳Beijing, China
Investigational Site Number 156005
🇨🇳Shijiazhuang, China
Investigational Site Number 156004
🇨🇳Taiyuan, China
Investigational Site Number 156008
🇨🇳Wuhan, China
Investigational Site Number 156017
🇨🇳Chengdu, China
Investigational Site Number 156022
🇨🇳Guangzhou, China
Investigational Site Number 156011
🇨🇳Hangzhou, China
Investigational Site Number 156012
🇨🇳Hefei, China
Investigational Site Number 156019
🇨🇳Changchun, China
Investigational Site Number 156018
🇨🇳Beijing, China
Investigational Site Number 156002
🇨🇳Beijing, China
Investigational Site Number 156014
🇨🇳Guangzhou, China
Investigational Site Number 156020
🇨🇳Jinan, China
Investigational Site Number 156010
🇨🇳Shanghai, China
Investigational Site Number 156006
🇨🇳Shanghai, China
Investigational Site Number 156009
🇨🇳Shanghai, China