MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00854035
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
266 participants
INTERVENTIONAL
2009-02-28
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
DOUBLE
Study Groups
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E
MK-0431/ONO-5435
Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD
P
MK-0431/ONO-5435
Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 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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MK-0431/ONO-5435
Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD
MK-0431/ONO-5435
Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 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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Seki Akiteru
Role: STUDY_CHAIR
First Division Clinical Development Planning I
Locations
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Chugoku Region
Chugoku, , Japan
Chubu Region
Chūbu, , Japan
Hokuriku Region
Hokuriku, , Japan
Kanto Region
Kanto, , Japan
Kinki Region
Kinki, , Japan
Kyushu Region
Kyushu, , Japan
Tohoku Region
Tōhoku, , Japan
Countries
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Other Identifiers
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ONO-5435-15
Identifier Type: -
Identifier Source: org_study_id
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