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

May 7, 2014 updated by: Sanofi

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Investigational Site Number 156003
      • Beijing, China, 100853
        • Investigational Site Number 156002
      • Beijing, China, 100044
        • Investigational Site Number 156001
      • Beijing, China, 100088
        • Investigational Site Number 156016
      • Beijing, China, 100730
        • Investigational Site Number 156018
      • Changchun, China, 130041
        • Investigational Site Number 156019
      • Chengdu, China, 610083
        • Investigational Site Number 156017
      • Guangzhou, China, 510080
        • Investigational Site Number 156014
      • Guangzhou, China, 510150
        • Investigational Site Number 156022
      • Hangzhou, China, 310003
        • Investigational Site Number 156011
      • Hefei, China, 230001
        • Investigational Site Number 156012
      • Jinan, China, 250012
        • Investigational Site Number 156020
      • Jinan, China, 250021
        • Investigational Site Number 156023
      • Shanghai, China, 200040
        • Investigational Site Number 156010
      • Shanghai, China, 200072
        • Investigational Site Number 156006
      • Shanghai, China, 200080
        • Investigational Site Number 156009
      • Shenyang, China, 110022
        • Investigational Site Number 156021
      • Shijiazhuang, China, 050051
        • Investigational Site Number 156005
      • Taiyuan, China, 030001
        • Investigational Site Number 156004
      • Tianjin, China, 300052
        • Investigational Site Number 156024
      • Wuhan, China, 430022
        • Investigational Site Number 156008
      • Xiamen, China, 361003
        • Investigational Site Number 156015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMARYL M (Glimepiride and Metformin hydrochloride combination)
AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal
Drug: Glimepiride and Metformin hydrochloride combination (HOE490)
Pharmaceutical form:tablet Route of administration: oral
Active Comparator: AMARYL (Glimepiride)
AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal
Drug: Glimepiride (HOE490)
Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in HbA1c
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively
Time Frame: 20 weeks, at week 20
20 weeks, at week 20
Absolute change in Fasting Plasma Glucose
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20
Number of patients reporting adverse events
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20
Number of patients reporting serious adverse events
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20
Hypoglycemia
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20
Vital signs
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20
Hematology, Serum chemistry and lipids
Time Frame: 20 weeks, from baseline to week 20
20 weeks, from baseline to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC11761
  • U1111-1121-6792 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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