Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6972
Source ID: NCT02956811
Associated Drug: Dapagliflozin
Title: Does Dapagliflozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?
Acronym: DAPA-LVH
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Left Ventricular Hypertrophy
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change in left ventricular (LV) Mass by Cardiac MRI at 52 weeks, To see if Dapagliflozin reduces LV mass more than placebo in participants with type 2 diabetes and LV hypertrophy, Baseline and 52 weeks | Secondary: Change in 24 hour blood pressure (BP) recording at 52 weeks, To confirm expected effect of dapagliflozin on BP, Baseline and 52 weeks|Change in Office blood pressure (BP) at 4, 17, 34 and 52 weeks, To confirm expected effect of dapagliflozin on BP, Baseline, 4, 17, 34 and 52 weeks|Change in Body mass index at 4, 17, 34 and 52 weeks, To confirm expected effect of dapagliflozin on body mass index, Baseline 4, 17, 34 and 52 weeks|Change in waist/hip ratio at 4, 17, 34 and 52 weeks, To confirm expected effect of dapagliflozin on waist/hip ratio, Baseline 4, 17, 34 and 52 weeks|Change in waist circumference at 4, 17, 34 and 52 weeks, To confirm expected effect of dapagliflozin on waist circumference, Baseline 4, 17, 34 and 52 weeks|Change in visceral fat massed with Abdominal MRI at 52 weeks, To assess the effect of dapagliflozin on visceral fat mass., Baseline and 52 weeks|Change in HbA1c at 4, 17, 34 and 52 weeks, To assess the effects of dapagliflozin on HbA1c, Baseline, 4, 17, 34 and 52 weeks|Number of patients with adverse events related to treatment, Urinary symptoms and hypotensive symptoms will assess the tolerability of dapagliflozin in this patient group, 4, 17, 34 and 52 weeks|Number of participants with abnormal laboratory values, Liver function tests will assess the tolerability of dapagliflozin in this patient group, 4, 17, 34 and 52 weeks|Change in Fasting Insulin Resistance Index (FIRI) at 4, 17, 34 and 52 weeks, To assess the effects of dapagliflozin on FIRI, Baseline, 4, 17, 34 and 52 weeks|Change in B-type Natriuretic Peptide (BNP) at 4, 17, 34 and 52 weeks, To assess the effects of dapagliflozin on BNP, Baseline, 4, 17, 34 and 52 weeks|Change in uric acid at 4, 17, 34 and 52 weeks, To assess the effects of dapagliflozin on uric acid, Baseline, 4, 17, 34 and 52 weeks|Change in diastolic function and global longitudinal strain, To assess the effect of dapagliflozin on left ventricular diastolic function, Baseline and 52 weeks
Sponsor/Collaborators: Sponsor: University of Dundee | Collaborators: NHS Tayside|AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-02-14
Completion Date: 2019-04-02
Results First Posted:
Last Update Posted: 2019-07-09
Locations: Ninewells Hospital, Dundee, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02956811