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: May 7, 2014
Last verified: May 2014

October 20, 2011
May 7, 2014
October 2011
February 2013   (final data collection date for primary outcome measure)
Absolute change in HbA1c [ Time Frame: 20 weeks, from baseline to week 20 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01457911 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Glimepiride and Metformin hydrochloride combination (HOE490)
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: Glimepiride (HOE490)
    Pharmaceutical form:tablet Route of administration: oral
  • 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
    Intervention: Drug: Glimepiride and Metformin hydrochloride combination (HOE490)
  • Active Comparator: AMARYL (Glimepiride)
    AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal
    Intervention: Drug: Glimepiride (HOE490)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
February 2013
February 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01457911
EFC11761, U1111-1121-6792
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP