Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
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
2 other identifiers
interventional
189
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started May 2009
Shorter than P25 for phase_3 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 31, 2011
August 1, 2011
10 months
June 18, 2009
August 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in HbA1c from baseline
24 weeks
Secondary Outcomes (1)
Change in the ratio patients with < 7.0% of HbA1c
24 weeks
Study Arms (2)
1
EXPERIMENTALMetformin 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
2
PLACEBO COMPARATORPlacebo 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaku Kohei, Professor
Kawasaki Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2009
First Posted
June 19, 2009
Study Start
May 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 31, 2011
Record last verified: 2011-08