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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 19, 2014