Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
NCT ID: NCT00575874
Last Updated: 2009-02-09
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
150 participants
INTERVENTIONAL
2007-08-31
2009-01-31
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
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
Rivoglitazone HCl
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
2
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
rivoglitazone HCl
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
3
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
rivoglitazone HCl
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
4
30 mg pioglitazone HCl capsules once daily for 12 weeks
pioglitazone HCl
30 mg capsules once daily for 12 weeks
5
Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules
placebo
matching tablets or capsule once daily for 12 weeks
Interventions
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Rivoglitazone HCl
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
rivoglitazone HCl
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
rivoglitazone HCl
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
pioglitazone HCl
30 mg capsules once daily for 12 weeks
placebo
matching tablets or capsule once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* HbA1c \>6.5% and \<10.0%
* FPG \>126 mg/dL (7 mmol/L) and \< 270 mg/dL (15 mmol/L)
Exclusion Criteria
* History of ketoacidosis
* Current insulin therapy
* C-peptide \<0.5ng/mL
* Imparied hepatic function
* NYHA Class II-IV cardiac status or hospitalization for CHF or EF\<40%
* uncontrolled hypertension
20 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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The Chinese University of Hong Kong
Locations
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Hong Kong, , China
Countries
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Other Identifiers
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CS011-A-J205
Identifier Type: -
Identifier Source: org_study_id
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