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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01457911
First received: October 20, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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).

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Glimepiride and Metformin hydrochloride combination (HOE490)
Drug: Glimepiride (HOE490)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, 2-arm Parallel Group, 20-week Study Comparing the Efficacy and Safety of Fixed Dose Combination of Glimepiride and Metformin (AMARYL M 1/250mg) Versus Glimepiride (AMARYL) in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change in HbA1c [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively [ Time Frame: 20 weeks, at week 20 ] [ Designated as safety issue: No ]
  • Absolute change in Fasting Plasma Glucose [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]
  • Number of patients reporting adverse events [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]
  • Number of patients reporting serious adverse events [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]
  • Hematology, Serum chemistry and lipids [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457911

Locations
China
Investigational Site Number 156002
Beijing, China, 100853
Investigational Site Number 156003
Beijing, China, 100730
Investigational Site Number 156016
Beijing, China, 100088
Investigational Site Number 156001
Beijing, China, 100044
Investigational Site Number 156018
Beijing, China, 100730
Investigational Site Number 156019
Changchun, China, 130041
Investigational Site Number 156017
Chengdu, China, 610083
Investigational Site Number 156022
Guangzhou, China, 510150
Investigational Site Number 156014
Guangzhou, China, 510080
Investigational Site Number 156011
Hangzhou, China, 310003
Investigational Site Number 156012
Hefei, China, 230001
Investigational Site Number 156023
Jinan, China, 250021
Investigational Site Number 156020
Jinan, China, 250012
Investigational Site Number 156009
Shanghai, China, 200080
Investigational Site Number 156006
Shanghai, China, 200072
Investigational Site Number 156010
Shanghai, China, 200040
Investigational Site Number 156021
Shenyang, China, 110022
Investigational Site Number 156005
Shijiazhuang, China, 050051
Investigational Site Number 156004
Taiyuan, China, 030001
Investigational Site Number 156024
Tianjin, China, 300052
Investigational Site Number 156008
Wuhan, China, 430022
Investigational Site Number 156015
Xiamen, China, 361003
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01457911     History of Changes
Other Study ID Numbers: EFC11761, U1111-1121-6792
Study First Received: October 20, 2011
Last Updated: April 23, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013