Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00363519
Last Updated: 2012-06-14
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
PHASE3
195 participants
INTERVENTIONAL
2006-08-31
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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P
Placebo
Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
E
Sitagliptin phosphate
Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
Interventions
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Placebo
Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
Sitagliptin phosphate
Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Mikio Nishii
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Chugoku Region
Chugoku, , Japan
Chubu Region
Chūbu, , Japan
Hokkaido Region
Hokkaido, , Japan
Kanto Region
Kanto, , Japan
Kinki Region
Kinki, , Japan
Kyushu Region
Kyushu, , Japan
Shikoku Region
Shikoku, , Japan
Tohoku Region
Tōhoku, , Japan
Countries
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Other Identifiers
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ONO-5435-09
Identifier Type: -
Identifier Source: org_study_id
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