Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457911
• Other study ID #: EFC11761
• Secondary ID: U1111-1121-6792
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2011
• Last updated: May 7, 2014
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Glimepiride and Metformin hydrochloride combination (HOE490)
Pharmaceutical form:tablet Route of administration: oral
• Glimepiride (HOE490)
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156002	Beijing
China	Investigational Site Number 156003	Beijing
China	Investigational Site Number 156016	Beijing
China	Investigational Site Number 156018	Beijing
China	Investigational Site Number 156019	Changchun
China	Investigational Site Number 156017	Chengdu
China	Investigational Site Number 156014	Guangzhou
China	Investigational Site Number 156022	Guangzhou
China	Investigational Site Number 156011	Hangzhou
China	Investigational Site Number 156012	Hefei
China	Investigational Site Number 156020	Jinan
China	Investigational Site Number 156023	Jinan
China	Investigational Site Number 156006	Shanghai
China	Investigational Site Number 156009	Shanghai
China	Investigational Site Number 156010	Shanghai
China	Investigational Site Number 156021	Shenyang
China	Investigational Site Number 156005	Shijiazhuang
China	Investigational Site Number 156004	Taiyuan
China	Investigational Site Number 156024	Tianjin
China	Investigational Site Number 156008	Wuhan
China	Investigational Site Number 156015	Xiamen

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in HbA1c		20 weeks, from baseline to week 20	No
Secondary	Percentage of patients reaching HbA1c < 7% or HbA1c = 6.5%, respectively		20 weeks, at week 20	No
Secondary	Absolute change in Fasting Plasma Glucose		20 weeks, from baseline to week 20	No
Secondary	Number of patients reporting adverse events		20 weeks, from baseline to week 20	No
Secondary	Number of patients reporting serious adverse events		20 weeks, from baseline to week 20	No
Secondary	Hypoglycemia		20 weeks, from baseline to week 20	No
Secondary	Vital signs		20 weeks, from baseline to week 20	No
Secondary	Hematology, Serum chemistry and lipids		20 weeks, from baseline to week 20	No