Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00924573

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	180
Study Start Date:	June 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator 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-Aventis

Investigators

Principal Investigator:

Kaku Kohei, Professor

Kawasaki Medical University

More Information

No publications provided

Responsible Party:	sanofi-aventis ( International Clinical Development Study Director )
Study ID Numbers:	EFC10846, HOE490/4045
Study First Received:	June 18, 2009
Last Updated:	November 10, 2009
ClinicalTrials.gov Identifier:	NCT00924573 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi-Aventis:

Glimepiride
Metformin
Combination Drug Therapy

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010