Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4020
Source ID: NCT00554450
Associated Drug: Dapagliflozin
Title: Renal Impairment in Type 2 Diabetic Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Dapagliflozin
Outcome Measures: Primary: Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine, on Days -1, 1, 4 and 10|Blood samples for serum glucose and creatinine will be collected, on Days -1, 1, 4 and 10 at selected timepoints|Blood and urine PK samples, on Days 1, 4, 10|Iohexol PK blood & urine samples for GFR assessment, on Day -12 to -5 | Secondary: AEs, vital signs, scr, Days -1, 1, 4-11, discharge|physical exams, scr, Days -12 to -5, -1, discharge|ECGs, scr, Days,-1, 4, 7, discharge|clinical labs, scr, Day -1, 1, 4, 6, 8, 10, discharge|The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only), on Days -1, 1, 4 and 10
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-03
Completion Date: 2008-10
Results First Posted:
Last Update Posted: 2016-10-17
Locations: Advanced Clinical Research Institute, Anaheim, California, 92801, United States|Elite Research Institute, Miami, Florida, 33169, United States|Prism Research, St. Paul, Minnesota, 55114, United States|Dgd Research, Inc., San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT00554450