| Trial ID: | L4062 |
| Source ID: | NCT00857558
|
| Associated Drug: |
Saxagliptin
|
| Title: |
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes, Type 2
|
| Interventions: |
DRUG: saxagliptin|DRUG: saxagliptin|DRUG: saxagliptin|DRUG: placebo
|
| Outcome Measures: |
Primary: changes in HbA1C from baseline, 2w, 4w, 8w, 12w, 16w | Secondary: values and changes in HbA1c form baseline, 2w, 4w, 8w, 12w, 16w|values and changes in fasting blood glucose (FSB) from baseline, 2w, 4w, 8w, 12w, 16w|adverse event, at any time
|
| Sponsor/Collaborators: |
Sponsor: Kyowa Kirin Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
350
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01
|
| Completion Date: |
2010-05
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-09
|
| Locations: |
Chubu regin, Japan|Chugoku region, Japan|Hokkaido region, Japan|Kanto region, Japan|Kinki region, Japan|Kyushu region, Japan|Shikoku region, Japan|Tohoku region, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00857558
|
