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

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ClinicalTrials.gov Identifier: NCT00924573
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Metformin Drug: placebo Drug: Glimepiride (HOE490) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Changes in HbA1c from baseline [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change in the ratio patients with < 7.0% of HbA1c [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924573


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00924573     History of Changes
Other Study ID Numbers: EFC10846
HOE490/4045
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

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
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors