| Trial ID: | L2123 |
| Source ID: | NCT00997282
|
| Associated Drug: |
Opc-262 2.5 Mg
|
| Title: |
A Study of OPC-262 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2
|
| Interventions: |
DRUG: OPC-262 2.5 mg|DRUG: OPC-262 5 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Changes in HbA1C from baseline, Week 24 (LOCF) | Secondary: Changes in fasting blood glucose (FBG) from baseline, Week 24|Changes in 2 hour postprandial blood glucose (PPG) from baseline, Week 24|Changes in 3 hour PPG AUC from baseline, Week 24
|
| Sponsor/Collaborators: |
Sponsor: Kyowa Kirin Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
255
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-09
|
| Completion Date: |
2010-10
|
| Results First Posted: |
|
| Last Update Posted: |
2014-01-08
|
| Locations: |
Chubu Region, Japan|Chugoku Region, Japan|Kansai Region, Japan|Kanto Region, Japan|Kyushu Region, Japan|Shikoku Region, Japan|Tohoku Region, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00997282
|
