Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity

Sponsor
Giaccari Andrea
Study ID
NCT03313752
Phase
PHASE3
Status
Completed

Conditions

  • Stable Coronary Artery Disease
  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    Dapagliflozin, will be administered according to the approved posology and to the approved dose as stated by Local Health Indication and by the Drug Brochure
  • Placebo — OTHER
    placebo

Study Details

A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase. Subjects: Type 2 diabetic patients and coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable at time of screening visit, with suboptimal glycaemic control (HbA1c 7.0-8.5%) on their current anti-hyperglycaemic regimen Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo. Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1. The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control. The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control, and with coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable, who have already undergone, under routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess the cardiovascular function. Thus, the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice (according to Standards of Care).

Key Dates

Start date
Dec 1, 2017
Status verified
May 2026
Primary completion
Oct 6, 2022
Completion
Oct 6, 2022

Study Design

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

Arms

  • Placebo Comparator: A - placebo
    Green, plain, diamond shaped, film coated tablet (orally), not containing active ingredient; once daily, for 4 weeks
  • Experimental: B - experimental drug
    Dapagliflozin tablet available at dose of 10 mg, once daily, for 4 weeks

Primary Outcome Measure

Effect of dapagliflozin on myocardial insulin sensitivity [ Time Frame: 4 weeks ]

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