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Completed

NCT Number: NCT01457911

Evaluation of Fixed Dose Combination of Glimepiride and Metformin 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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 156001, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glimepiride and Metformin hydrochloride combination (HOE490)

Drug

Pharmaceutical form:tablet Route of administration: oral

GLIMEPIRIDE (HOE490)

Drug

Pharmaceutical form:tablet Route of administration: oral

Primary outcomes

  1. Absolute change in HbA1c

    Time frame: 20 weeks, from baseline to week 20

Secondary outcomes

  1. Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively

    Time frame: 20 weeks, at week 20

  2. Absolute change in Fasting Plasma Glucose

    Time frame: 20 weeks, from baseline to week 20

  3. Number of patients reporting adverse events

    Time frame: 20 weeks, from baseline to week 20

  4. Number of patients reporting serious adverse events

    Time frame: 20 weeks, from baseline to week 20

  5. Hypoglycemia

    Time frame: 20 weeks, from baseline to week 20

  6. Vital signs

    Time frame: 20 weeks, from baseline to week 20

  7. Hematology, Serum chemistry and lipids

    Time frame: 20 weeks, from baseline to week 20

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2011
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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