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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00924573 |
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Date of registration:
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18/06/2009 |
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Primary sponsor: |
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Public title:
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Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
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Scientific title:
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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 |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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189 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00924573 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kaku Kohei, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kawasaki Medical University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
74 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: Glimepiride (HOE490)
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Drug: Metformin
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Drug: placebo
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Primary Outcome(s)
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Changes in HbA1c from baseline
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Change in the ratio patients with < 7.0% of HbA1c
[Time Frame: 24 weeks]
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Secondary ID(s)
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EFC10846
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HOE490/4045
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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