Effects of empagliFlozin on myocardIal metabOlic Rate of glucosE Estimated Through 18FDG PET (FIORE Study)

• Status: Unknown status
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes is an independent risk factor for ischemic heart disease (CAD) and heart failure, and cardiovascular diseases are the main cause of mortality and morbidity in patients with diabetes. Recent studies on cardiovascular outcomes have shown that type 2 sodium glucose co-transporter (SGLT-2i) inhibitors are not only effective in improving glycometabolic control, but are also able to reduce major CV events (MACE) and hospitalization for heart failure. However, it is still unclear whether the beneficial CV effects of treatment with SGLT2i are due to indirect mechanisms such as reduction in blood pressure, improvement of vascular stiffness, reduction in body weight and visceral adiposity, reduction in uricemia or whether they have effects direct on the heart. Recently, it was shown that in nondiabetic porcine model with heart failure, the treatment with empagliflozin was associated with a switch of myocardial fuel utilization from glucose uptake toward uptake of ketone bodies and free fatty acid, thereby improving myocardial energetics, enhancing LV systolic function, and ameliorating adverse LV remodeling.

It is not known whether empagliflozin treatment is able to modify the heart's energy metabolism even in humans.

In this study we hypothesize that empagliflozin may determine beneficial CV effects reducing myocardial metabolic rate of glucose assessed by hyperinsulinemic euglycemic clamp 18F-FDG PET scans in patients with type 2 diabetes.

This is a single-center, prospective, controlled, randomized, open-label, two parallel group and switch, active-comparator study that evaluates the comparative effects of 26 weeks of treatment with empagliflozin versus glimepiride add on metformin on myocardial metabolic rate of glucose estimated through 18F-FGD-PET scan in patients with type 2 diabetes without a history of coronary heart disease. At the end of 26 weeks of treatment, subjects belonging to the first group will be shifted to glimepiride therapy, while subjects belonging to the second group will be shifted to empagliflozin treatment for 26 weeks. All subjects, then, will control themselves.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Catanzaro
• Treatments: Empagliflozin; Glimepiride

Criteria

Inclusion Criteria:

• Type 2 diabetes, in treatment with metformin

• Written informed consent

Exclusion Criteria:

• Type 1 diabetes

• eGFR <60 ml/min/1.73 m2. or dialysis patients

• HbA1c <6.5 o >9%

• Previous treatment with insulin (except for short-term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator), with SGLT2 inhibitors or with GLP-1R agonists or DPPIV inhibitors

• Patients who do not tolerate empagliflozin and/or glimepiride or in whom empagliflozin and/or glimepiride are contraindicated

• Uncontrolled hypertension (BP>140/90 mmHg)

• Prior cardio- cerebral-vascular events

• Hepatic disease

• Pathology neoplastic (past or present)

• Pregnancy women or childbearing female without adequate and approved birth control method