Clinical Trial Details
| Trial ID: | L2395 |
| Source ID: | NCT00538174 |
| Associated Drug: | Dapagliflozin |
| Title: | Phase I Multiple-Ascending Dose (Japan) |
| Acronym: | MAD |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Dapagliflozin|DRUG: placebo |
| Outcome Measures: | Primary: AEs, vital signs & physical exam, scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21|ECGs, scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21|Clinical labs, scr, Days -1, 2, 7, 12, 14, 15, 21|Urine safety markers, Days -1, 1, 14 | Secondary: 24 hr PK blood & urine samples, Days 1 & 14|Serum glucose, serum insulin, serum c-peptide, Days -1, 1, 14|Serum fructosamine, Days -1, 14, 4 h|OGTT, Days -2, 13 (after 10 h fast)|24h urine, Days -1, 1 & 14 for glucose, creatinine & calcium |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 36 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-11 |
| Completion Date: | 2008-05 |
| Results First Posted: | |
| Last Update Posted: | 2015-03-23 |
| Locations: | Local Institution, Suita, Osaka, 5650853, Japan |
| URL: | https://clinicaltrials.gov/show/NCT00538174 |
