| Trial ID: | L3376 |
| Source ID: | NCT01505426
|
| Associated Drug: |
Asp1941
|
| Title: |
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type II Diabetes Mellitus
|
| Interventions: |
DRUG: ASP1941|DRUG: metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline to end of treatment, Baseline and up to 24 weeks | Secondary: Change in fasting plasma glucose level, Baseline and up to 24 weeks|Change in fasting serum insulin level, Baseline and up to 24 weeks|Change in body weight, Baseline and up to 24 weeks|Change in waist circumference, Baseline and up to 24 weeks|Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG, For 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
171
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-11-28
|
| Completion Date: |
2013-01-14
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Busan, Korea, Republic of|Daegu, Korea, Republic of|Daejeon, Korea, Republic of|Gwangju, Korea, Republic of|Incheon, Korea, Republic of|Jeonju, Korea, Republic of|Seoul, Korea, Republic of|Wonju, Korea, Republic of|Kaohsiung, Taiwan|Taichung, Taiwan|Tainan, Taiwan|Taipei, Taiwan
|
| URL: |
https://clinicaltrials.gov/show/NCT01505426
|
