Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial

Sponsor
Mackay Memorial Hospital
Study ID
NCT03871621
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Diabetes Medicines — DRUG
    Anti-diabetic medications except SGLT2 inhibitors
  • Dapagliflozin — DRUG
    Dapagliflozin tablet (10 mg)

Study Details

The primary purpose of this study is to evaluate the efficacy of the SGLT2 inhibitor dapagliflozin, as compared with standard care of diabetes, on left ventricular (LV) structural and functional change in asymptomatic type 2 diabetes mellitus (DM) patient.

Key Dates

Start date
Apr 1, 2019
Status verified
Mar 2023
Primary completion
May 1, 2022
Completion
Aug 31, 2022

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin add-on group
    T2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to Dapagliflozin (10 mg/qd) add-on group.
  • Active Comparator: Standard of care (SOC) group
    T2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to SOC treatment group.

Primary Outcome Measure

Cardiac global longitudinal strain (GLS) [ Time Frame: Baseline to Week 24 ]

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