Clinical Trial Details
| Trial ID: | L2755 |
| Source ID: | NCT01672762 |
| Associated Drug: | Ipragliflozin |
| Title: | A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: ipragliflozin |
| Outcome Measures: | Primary: Change in HbA1c, Before and at 4-, 8-, 12-, 16-, 20- and 24-week | Secondary: Change in fasting plasma glucose, Before and at 4-, 8-, 12-, 16-, 20- and 24-week|Change in fasting serum insulin, Before and at 4-, 8-, 12-, 16-, 20- and 24-week|Change in waist circumference, Before and at 4-, 8-, 12-, 16-, 20- and 24-week|Change in body weight, Before and at 4-, 8-, 12-, 16-, 20- and 24-week|Change in urine glucose, Before and at 4-, 8-, 12-, 16-, 20- and 24-week|Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Astellas Pharma Inc |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 174 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-05-25 |
| Completion Date: | 2013-04-13 |
| Results First Posted: | |
| Last Update Posted: | 2024-11-08 |
| Locations: | Chubu, Japan|Hokkaido, Japan|Kansai, Japan|Kantou, Japan|Kyushu, Japan|Shikoku, Japan|Touhoku, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01672762 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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