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Completed

NCT Number: NCT00924573

Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.

Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

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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

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

About this study

Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise
  • Patients who gave informed consent to participate in the study

Exclusion criteria

  • Patients with HbA1c of < 7.0 % and > 11.0 %
  • Patients with any following laboratory test abnormality :
  • ALT and/or AST: > 3 X ULN
  • Neutrophils: < 1,000/mm3 and/or platelets < 100,000/mm3
  • Hemoglobin: <11 g/dL
  • Creatinine: >= 1.3 mg/dL in case of male or >= 1.0 mg/dL in case of female

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

metformin

Drug

oral administration

Placebo

Drug

oral administration

GLIMEPIRIDE (HOE490)

Drug

oral administration

Primary outcomes

  1. Changes in HbA1c from baseline

    Time frame: 24 weeks

Secondary outcomes

  1. Change in the ratio patients with < 7.0% of HbA1c

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Double-blinded Comparative Study to Investigate the Efficacy and Safety of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride in Patients With T2DM Inadequately Treated With Constant Dose of Glimepiride

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 19, 2009
Registry last updated
Aug 31, 2011

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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