| Trial ID: | L5088 |
| Source ID: | NCT01517321
|
| Associated Drug: |
Mk-0431/Ono-5435
|
| Title: |
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: MK-0431/ONO-5435|DRUG: Placebo, MK-0431/ONO-5435
|
| Outcome Measures: |
Primary: Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability, 12 weeks and 52 weeks | Secondary: HbA1c, 12 weeks|2-hour postmeal glucose, 12 weeks|Fasting plasma glucose, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Ono Pharmaceutical Co. Ltd | Collaborators: MSD K.K.
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
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| Completion Date: |
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| Results First Posted: |
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| Last Update Posted: |
2013-07-09
|
| Locations: |
Chubu Region Clinical Site, Chubu, Japan|Chugoku Region Clinical Site, Chugoku, Japan|Kanto Region Clinical Site, Kanto, Japan|Kinki Region Clinical Site, Kinki, Japan|Kyusyu Region Clinical Site, Kyusyu, Japan|Tohoku Region Clinical Site, Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01517321
|
