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Clinical Trial Details

Trial ID: L2741
Source ID: NCT03007329
Associated Drug: Exenatide
Title: Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus.
Acronym: EXENDA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Steatosis, Liver|Type2 Diabetes
Interventions: DRUG: Exenatide|DRUG: Exenatide matching Placebo|DRUG: Dapagliflozin
Outcome Measures: Primary: change in hepatic lipid content measured with magnetic resonance spectroscopy in %, to investigate the effects on hepatic lipid content reduction of combination therapy with dapagliflozin (10mg daily) and exenatide (2mg weekly) compared to dapagliflozin (10mg daily) and placebo given for 24 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite oral therapy., baseline - week 24 | Secondary: change in myocardial lipid content measured with magnetic resonance spectroscopy in %, to investigate the effects on myocardial lipid content reduction of combination therapy with dapagliflozin (10mg daily) and exenatide (2mg weekly) compared to dapagliflozin (10mg daily) and placebo given for 24 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite oral therapy., baseline - week 24|change in pancreatic lipid content measured with magnetic resonance spectroscopy in %, to investigate the effects on pancreatic lipid content reduction of combination therapy with dapagliflozin (10mg daily) and exenatide (2mg weekly) compared to dapagliflozin (10mg daily) and placebo given for 24 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite oral therapy., baseline - week 24|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, safety and tolerability from baseline to end by number of participants with treatment related AEs and SAEs, baseline- week 24|Quality of Life questionnaire, change from baseline in quality of live assessed by WHO Well Being Index, baseline - week 24|change in insulin resistance, change from baseline in insulin resistance assessed by HOMA IR Index, baseline - week 24|change in insulin sensitivity, change from baseline in insulin sensitivity assessed by OGIS, baseline - week 24|energy expenditure, change from baseline of energy expenditure assessed by indirect calorimetry, baseline -week 24|energy intake, change from baseline of energy intake assessed by 3 day eating protocols, baseline -week 24|blood pressure, To assess the effect of combination therapy with dapagliflozin and exenatide on blood pressure compared to dapagliflozin and placebo., baseline - week 24|weight loss, To assess the effect of combination therapy with dapagliflozin and exenatide on weight loss compared to dapagliflozin and placebo., baseline - week 24.|change in glomerular filtration rate, change in GFR from baseline, baseline -week 24 | Other: weight, change in weight from baseline, baseline - week 24|hip circumference, change in hip circumference from baseline, baseline - week 24|waist circumference, change in waist circumference from baseline, baseline - week 24|fasting glucose, change in fasting plasma glucose from baseline, baseline - week 24|HbA1c reduction >= 0.5%, % of patient with HbA1c reduction of more than 0.5%, baseline - week 24|weight reduction >= 5%, % of patient with weight reduction of more than 5%, baseline - week 24|change in triglycerides, change in triglycerides from baseline, baseline - week 24|change in cholesterol, change in cholesterol from baseline, baseline - week 24
Sponsor/Collaborators: Sponsor: Medical University of Vienna | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-03-08
Completion Date: 2020-01-16
Results First Posted:
Last Update Posted: 2022-04-15
Locations: Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III, Wien, 1090, Austria
URL: https://clinicaltrials.gov/show/NCT03007329