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Clinical Trial Details

Trial ID: L2316
Source ID: NCT03074630
Associated Drug: Dapagliflozin
Title: Dapagliflozin and Cholesterol Metabolism in Type 2 Diabetes (DM2)
Acronym: DICE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03074630/results
Conditions: Diabetes Mellitus, Type 2|Hypercholesterolemia
Interventions: DRUG: Dapagliflozin|DRUG: Rosuvastatin
Outcome Measures: Primary: Change in Plasma LDL Cholesterol, Before and after 5 weeks of dapagliflozin on rosuvastatin background., 5 weeks | Secondary: Change in Plasma HDL Cholesterol, Change in plasma HDL cholesterol following dapagliflozin, 12 weeks|Change in Total Cholesterol, Change in total cholesterol following dapagliflozin, 5 weeks|Change in Plasma Triglycerides, Change in plasma Triglycerides following dapagliflozin, 5 weeks|Change in Plasma FFA, Change in plasma FFA following dapagliflozin, 5 weeks|Change in Cholesterol Fluxes, Including cholesterol production, cholesterol excretion, cholesterol degradation. Before and after 5 weeks of dapagliflozin on rosuvastatin background., 5 weeks|Change in Triglyceride Fluxes, Including cholesterol production, cholesterol excretion, cholesterol degradation. Before and after 5 weeks of dapagliflozin on rosuvastatin background, 5 weeks|Change in Peripheral Insulin Sensitivity, Before and after 5 weeks of dapagliflozin on rosuvastatin background, measured as glucose disposal during hyperinsulinemic euglycemic clamp, 5 weeks|Liver Fat MRI Spectrum, Before and after 5 weeks of dapagliflozin on rosuvastatin background, 5 weeks|Fecal Microbiome Composition, Before and after 5 weeks of dapagliflozin on rosuvastatin background, different bacterial strains will be quantified in fresh fecal samples., 5 weeks|Bile Salt Excretion, Before and after 5 weeks of dapagliflozin on rosuvastatin background, 5 weeks|Urinary Glucose Excretion, Before and after 5 weeks of dapagliflozin on rosuvastatin background, 5 weeks|Urinary Sodium Excretion, Before and after 5 weeks of dapagliflozin on rosuvastatin background, 5 weeks
Sponsor/Collaborators: Sponsor: Amsterdam UMC, location VUmc | Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2016-05
Completion Date: 2018-04
Results First Posted: 2020-08-04
Last Update Posted: 2020-08-04
Locations: Academic Medical Center, Amsterdam, North Holland, 1105AZ, Netherlands
URL: https://clinicaltrials.gov/show/NCT03074630