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Clinical Trial Details

Trial ID: L5039
Source ID: NCT02462421
Associated Drug: Canagliflozin
Title: Pharmacogenetics of SGLT2 Inhibitors
Acronym: SGLT2iPGx
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02462421/results
Conditions: Diabetes Mellitus|Gout|Hyperuricemia
Interventions: DRUG: Canagliflozin
Outcome Measures: Primary: Urinary Excretion of Glucose (Measured During the 24 Hours Following Administration of Canagliflozin), The pharmacodynamic response to canagliflozin will be assessed by measuring the increase in 24 hour urinary glucose excretion., 24 hours after administration of canagliflozin|Change in Fractional Excretion of Uric Acid (the Difference Between Data After Administration of Canagliflozin Minus Data Before Administration of Canagliflozin), For the study arm focused on individuals with a genetic variant in SLC2A9, the pharmacodynamic response to canagliflozin will be assessed by measuring the absolute change in fractional excretion of uric acid in the urine. Fractional excretion of uric acid represents the fraction of the calculated filtered uric acid load (serum uric acid level multiplied by the measured creatinine clearance rate) that was excreted in the urine., 24 hour urine collection after administration of canagliflozin | Secondary: Canagliflozin-induced Change in Urinary Excretion of Sodium, The pharmacodynamic response to canagliflozin will be assessed by measuring the % increase in 24 hour urinary excretion of sodium., 24 hours after administration of canagliflozin|Canagliflozin-induced Change in Serum Creatinine, The pharmacodynamic response to canagliflozin will be assessed by measuring changes in serum creatinine, 24 hours after administration of canagliflozin|Canagliflozin-induced Change in Serum Uric Acid, The pharmacodynamic response to canagliflozin will be assessed by measuring changes in serum uric acid level, 24 hours after administration of canagliflozin|Canagliflozin-induced Change in Fasting Plasma Glucose, The magnitude of the change in fasting plasma glucose 24 hours after administration of canagliflozin (300 mg), 24 hrs
Sponsor/Collaborators: Sponsor: University of Maryland, Baltimore | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2015-06-01
Completion Date: 2021-12-31
Results First Posted: 2022-08-01
Last Update Posted: 2022-08-02
Locations:
URL: https://clinicaltrials.gov/show/NCT02462421