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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00924573
First received: June 18, 2009
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Metformin
Drug: placebo
Drug: Glimepiride (HOE490)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Changes in HbA1c from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the ratio patients with < 7.0% of HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Metformin on top of glimepiride

Twice a day with 2-6 mg of daily dose for glimepiride and 500-750mg of daily dose for metformin for 24 weeks

 Drug: Metformin
oral administration
Drug: Glimepiride (HOE490)
oral administration
Placebo Comparator: 2

Placebo on top of glimepiride

Twice a day with 2-6 mg of daily dose for glimepiride and 2-3 tablets of placebo for 24 weeks

 Drug: placebo
oral administration
Drug: Glimepiride (HOE490)
oral administration

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924573

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Kaku Kohei, Professor Kawasaki Medical University
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00924573     History of Changes
Other Study ID Numbers: EFC10846, HOE490/4045
Study First Received: June 18, 2009
Last Updated: August 30, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
Glimepiride
Metformin
Combination Drug Therapy

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 22, 2013