| Trial ID: | L5044 |
| Source ID: | NCT01242202
|
| Associated Drug: |
Ipragliflozin
|
| Title: |
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ipragliflozin|DRUG: alpha glucosidase inhibitor
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, baseline and 52 weeks | Secondary: Change from baseline in fasting plasma glucose, baseline and 52 weeks|Change from baseline in fasting serum insulin, baseline and 52 weeks|Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs), for 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
113
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-10-21
|
| Completion Date: |
2012-05-25
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Chubu, Japan|Hokkaido, Japan|Kansai, Japan|Kantou, Japan|Kyushu, Japan|Touhoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01242202
|
