Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes
NCT ID: NCT00575471
Last Updated: 2009-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2007-07-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks
Rivoglitazone HCl
0.5 mg tablets once daily for 12 weeks
2
rivoglitazone HCl 1 mg tablets once daily for 12 weeks
rivoglitazone HCl
1.0 mg tablets once daily for 12 weeks
3
rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks
rivoglitazone HCl
1.5 mg tablets once daily for 12 weeks
4
Matching placebo tablets once daily for 12 weeks
Placebo
Matching placebo tablets once daily for 12 weeks
Interventions
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Rivoglitazone HCl
0.5 mg tablets once daily for 12 weeks
rivoglitazone HCl
1.0 mg tablets once daily for 12 weeks
rivoglitazone HCl
1.5 mg tablets once daily for 12 weeks
Placebo
Matching placebo tablets once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* HbA1c \>6.5% and \<10%
* FPG \>126 mg/dL (7mmol/L) and \<270 mg/dL (15 mmol/L)
Exclusion Criteria
* history of ketoacidosis
* current insulin therapy
* C-peptide \<0.5ng/mL
* impaired hepatic function
* CHF or history of CHF (NYHA stage I - IV)
* uncontrolled hypertension
20 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Daiichi Sankyo Co. Ltd.
Locations
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Fukuoka, , Japan
Osaka, , Japan
Tokyo, , Japan
Countries
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Other Identifiers
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CS011-A-J204
Identifier Type: -
Identifier Source: org_study_id
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