Clinical Trial Details
| Trial ID: | L5017 |
| Source ID: | NCT02175784 |
| Associated Drug: | Ipragliflozin |
| Title: | A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: ipragliflozin|DRUG: placebo |
| Outcome Measures: | Primary: Change in HbA1C from baseline, Baseline and Week 16 | Secondary: Fasting plasma glucose, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Leptin concentration, Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52|Fructosamine concentration, Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52|Adiponectin concentration, Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52|Body weight, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Waist circumference, Baseline, Week 16, 24, 52|Blood glucose values of self monitoring, written in a diary, Baseline, Week 8, 16, 24, 52|Safety assessed by the adverse events, vital signs. and laboratory tests, Up to 52 Weeks |
| Sponsor/Collaborators: | Sponsor: Astellas Pharma Inc |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 262 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2014-03-31 |
| Completion Date: | 2015-12-07 |
| Results First Posted: | |
| Last Update Posted: | 2024-11-08 |
| Locations: | Chubu, Japan|Chugoku, Japan|Hokkaido, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan|Shikoku, Japan|Touhoku, Japan |
| URL: | https://clinicaltrials.gov/show/NCT02175784 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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