| Trial ID: | L4306 |
| Source ID: | NCT00854035
|
| Associated Drug: |
Mk-0431/Ono-5435
|
| Title: |
MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: MK-0431/ONO-5435|DRUG: MK-0431/ONO-5435
|
| Outcome Measures: |
Primary: HbA1c, 16 weeks|Safety and Tolerability, 16 weeks and 52 weeks | Secondary: 2 hour post-meal glucose, 16 weeks|Fasting plasma glucose, 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Ono Pharmaceutical Co. Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
266
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-14
|
| Locations: |
Chubu Region, Chubu, Japan|Chugoku Region, Chugoku, Japan|Hokuriku Region, Hokuriku, Japan|Kanto Region, Kanto, Japan|Kinki Region, Kinki, Japan|Kyushu Region, Kyushu, Japan|Tohoku Region, Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00854035
|
