Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2; Diastolic Dysfunction
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in
      addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function
      in patients with type 2 Diabetes mellitus.
    

Detailed description: 
      Diabetes is a serious and increasing global health burden. It has been shown, that diabetes
      is associated with a two-fold higher risk for coronary heart disease, stroke and for the
      aggregate of other vascular death independently of other conventional risk factors. It is the
      leading cause of cardiovascular disease.

      Diabetes mellitus substantially increases the risk of macrovascular and microvascular
      complications, such as vascular dysfunction with developing coronary, cerebrovascular, and
      peripheral arterial disease, heart failure, nerve disorders (neuropathy), eye complications
      (e.g. cataracts, glaucoma diabetic retinopathy), kidney disease (nephropathy), foot ulcers,
      restriction of mental function, and psychosomatic diseases (e.g. stress, anxiety and
      depression).

      The most common of the cardiovascular complications in diabetics are ischemic cardiomyopathy
      and left ventricular (LV) dysfunction. Of particular interest here is the diastolic
      dysfunction, as an early sign of diabetic heart muscle disease followed by systolic damage.

      Although diabetes has a decisive role in the development of cardiovascular disease,
      traditional glucose lowering agents have failed to convincingly show that intensive glucose
      control significantly reduces CVD events.

      A new approach for treatment of adult patients with type 2 diabetes was found with the
      selective inhibition of sodium glucose cotransporter 2 (SGLT2). Studies have shown that
      empagliflozin, a potent SGLT2 inhibitor, not only effectively reduces the rates of
      hyperglycemia but also blood pressure and weight. (16, 18) In addition, beneficial effects on
      arterial stiffness and vascular resistance, visceral adiposity, albuminuria and plasma urate
      have been reported.

      The results of the EMPA-REG OUTCOME study suggest that empagliflozin added to the standard
      therapy has a positive influence on cardiovascular outcomes and heart failure hospitalization
      in individuals with diabetic mellitus.

      The aim of the present study is to investigate the effects of empagliflozin, in comparison
      with placebo, on cardiac and vascular function as well as on cardiac biomarker in individuals
      with type 2 diabetes with standard therapy, increased E/E' ratio and poor glycemic control.
    

Intervention name(s): Empagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg per os daily for 12 weeks; amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks
Other intervention name(s): Jardiance
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: empagliflozin; diastolic function; poorly controlled type 2 diabetes mellitus