Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium
      glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with
      type 2 diabetes
    

Detailed description: 
      Obesity, and especially visceral/abdominal adiposity, is associated with diabetes and
      increased cardiovascular risk. In previous randomized, double-blind, placebo-controlled
      study, dapagliflozin reduced total body weight, predominantly by reducing fat mass, visceral
      adipose tissue and sc adipose tissue in type 2 diabetes. This study supported that caloric
      loss from glycosuria, and not fluid loss, was principally responsible for decrease in total
      body weight and fat mass. In fact, there have been several reports proving that inhibition of
      SGLT2 improves β-cell function and reduces body weight and blood pressure. However, effects
      of SGLT2 inhibitors on lipid profiles have not been decided yet in patients with type 2
      diabetes. Furthermore, there are few data to demonstrate the effects of SGLT2 inhibitors on
      CV risk.

      Many systems and pathways are involved in development of atherosclerosis in the arterial
      wall. Accumulating evidence suggests that endothelial dysfunction plays an important role
      particularly in the first stage of atherogenesis in patients with diabetes. Approaches
      designed to improve endothelial function may therefore have additional therapeutic value in
      the prevention and treatment of atherosclerotic disease. Endothelial dysfunction is related
      to decreased production and bioavailability of nitric oxide (NO). Endothelial function was
      measured through several circulating biomarker such as NO, endothelin-1 or non-invasive
      techniques such as flow-mediated dilation (FMD), skin laser doppler. Among them, FMD is known
      to as the optimal tool. In addition, several noninvasive techniques including measurement of
      the ankle-brachial index (ABI), carotid intima-media thickness (IMT) and pulse wave velocity
      (PWV) have been used for evaluation of atherosclerosis.

      If a participant's HbA1c dose not decreas by >0.4% at 12 weeks, rescue therapy can be added
      at the investigator's discretion.
    

Intervention name(s): Dapagliflozin; Gliclazide
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin 10 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (sitagliptin 100 mg) can be added at investigator's discretion.; Gliclazide MR 30 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (gliclazide MR 30 mg) can be added at investigator's discretion.
Other intervention name(s): Forxiga; Diamicron MR
Intervention MeSH terms: Dapagliflozin; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Atherosclerosis; Cardiovascular disease; Endothelial dysfunction; Vascular function; Dapagliflozin; Gliclazide