| Trial ID: | L2592 |
| Source ID: | NCT01054092
|
| Associated Drug: |
Ipragliflozin
|
| Title: |
A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ipragliflozin
|
| Outcome Measures: |
Primary: HbA1c, For 52 weeks | Secondary: Fasting plasma glucose, For 52 weeks|Fasting serum insulin, For 52 weeks|Plasma levels of ASP1941 for population PK analysis, For 52 weeks|Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs, For 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
182
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-01-14
|
| Completion Date: |
2011-07-22
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Chubu, Japan|Chugoku, Japan|Hokkaido, Japan|Kansai, Japan|Kantou, Japan|Kyushu, Japan|Touhoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01054092
|
