| Trial ID: | L5965 |
| Source ID: | NCT01008163
|
| Associated Drug: |
Yy-351/Placebo
|
| Title: |
A Dose-Finding, Efficacy and Safety Study of YY-351 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: YY-351/Placebo|DRUG: YY-351/Placebo|DRUG: YY-351|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in the fasting plasma glucose and postprandial glucose [after 2 hours, oral glucose tolerance test (OGTT) (75 g)] and HbA1c, from baseline to Week 8 | Secondary: Subjects achieving a glycemic response defined as ≤ 7.0%, from baseline to Week 8|Decrease of HbA1c > 0.5%, from baseline to Week 8|Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin], from baseline to Week 8|Body weight (or body composition), from baseline to Week 8|Waist girth, from baseline to Week 8|Homeostasis model assessment (HOMA), from baseline to Week 8|Lipid profile, from baseline to Week 8
|
| Sponsor/Collaborators: |
Sponsor: Yuyu Pharma, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2009-06
|
| Results First Posted: |
|
| Last Update Posted: |
2019-02-25
|
| Locations: |
Seoul National University Bundang Hospital, Seongnam, Bungdang-Gu, 463-707, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01008163
|
