Clinical trial NCT01457911: Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Official title: A Multicenter, Randomized, Open-label, 2-arm Parallel Group, 20-week Study Comparing the Efficacy and Safety of Fixed-dose Combination of 1 mg Glimepiride and 250 mg Metformin (AMARYL M 1/250 mg) Versus Glimepiride (AMARYL®) in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
* Signed written informed consent

Exclusion criteria:

* Type 1 diabetes mellitus
* HbA1c \< 7% or \> 10%
* Fasting plasma glucose \> 250 mg/dL (\> 13.9 mmol/L)
* Age \<18 years or Age ≥ 80 years
* Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
* Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Absolute change in HbA1c
timeFrame: 20 weeks, from baseline to week 20
Secondary outcomes:
measure: Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively
timeFrame: 20 weeks, at week 20
measure: Absolute change in Fasting Plasma Glucose
timeFrame: 20 weeks, from baseline to week 20
measure: Number of patients reporting adverse events
timeFrame: 20 weeks, from baseline to week 20
measure: Number of patients reporting serious adverse events
timeFrame: 20 weeks, from baseline to week 20
measure: Hypoglycemia
timeFrame: 20 weeks, from baseline to week 20
measure: Vital signs
timeFrame: 20 weeks, from baseline to week 20
measure: Hematology, Serum chemistry and lipids
timeFrame: 20 weeks, from baseline to week 20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156001
city: Beijing
country: China
facility: Investigational Site Number 156016
city: Beijing
country: China
facility: Investigational Site Number 156003
city: Beijing
country: China
facility: Investigational Site Number 156018
city: Beijing
country: China
facility: Investigational Site Number 156002
city: Changchun
country: China
facility: Investigational Site Number 156019
city: Chengdu
country: China
facility: Investigational Site Number 156017
city: Guangzhou
country: China
facility: Investigational Site Number 156014
city: Guangzhou
country: China
facility: Investigational Site Number 156022
city: Hangzhou
country: China
facility: Investigational Site Number 156011
city: Hefei
country: China
facility: Investigational Site Number 156012
city: Jinan
country: China
facility: Investigational Site Number 156020
city: Jinan
country: China
facility: Investigational Site Number 156023
city: Shanghai
country: China
facility: Investigational Site Number 156010
city: Shanghai
country: China
facility: Investigational Site Number 156006
city: Shanghai
country: China
facility: Investigational Site Number 156009
city: Shenyang
country: China
facility: Investigational Site Number 156021
city: Shijiazhuang
country: China
facility: Investigational Site Number 156005
city: Taiyuan
country: China
facility: Investigational Site Number 156004
city: Tianjin
country: China
facility: Investigational Site Number 156024
city: Wuhan
country: China
facility: Investigational Site Number 156008
city: Xiamen
country: China
facility: Investigational Site Number 156015
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: