Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Metformin (Drug); placebo (Drug); Glimepiride (HOE490) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Kaku Kohei, Professor, Principal Investigator, Affiliation: Kawasaki Medical University
Overall contact:
Public Registry ICD, Email: GV-Contact-us@sanofi-aventis.com
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
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Changes in HbA1c from baseline
Secondary outcome: Change in the ratio patients with < 7.0% of HbA1c
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
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
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.
Locations and Contacts
Public Registry ICD, Email: GV-Contact-us@sanofi-aventis.com
Sanofi-aventis Administrative Office, Tokyo, Japan; Recruiting
Additional Information
Starting date: June 2009
Ending date: April 2010
Last updated: October 1, 2009
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