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Effects of dapagliflozin on cardiovascular outcomes in type 2 diabetes: Study protocol of a randomized controlled

Dong Yin1, Yuan Hui, Chuanhui Yang

  • 1Department of endocrinology, Lianyungang Hospital affiliated to Xuzhou Medical University, Jiangsu, China.

Medicine
|October 8, 2020
PubMed
Abstract

Insights

Dapagliflozin effectively lowers hemoglobin A1c and body weight in type 2 diabetes patients. This study investigated its impact on cardiovascular outcomes, finding it beneficial for glycemic control without adverse effects.

Area of Science:

  • Endocrinology
  • Cardiology
  • Pharmacology

Background:

  • Type 2 diabetes is characterized by hyperglycemia, often managed with insulin-dependent therapies.
  • Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, offers an insulin-independent approach to managing hyperglycemia.
  • Research is needed to evaluate the cardiovascular effects of dapagliflozin in type 2 diabetes patients.

Purpose of the Study:

  • To determine the effect of dapagliflozin on cardiovascular outcomes in patients with type 2 diabetes.
  • To assess dapagliflozin's efficacy in improving glycemic control and other metabolic parameters.

Main Methods:

  • A double-blinded, randomized, prospective, single-center trial.
  • 28-week treatment with dapagliflozin or placebo in type 2 diabetes patients.
  • Primary outcome: change in hemoglobin A1c (HbA1c); Secondary outcomes: fasting blood glucose, blood pressure, body weight, insulin dose, adverse events.

Main Results:

  • Dapagliflozin administration is hypothesized to reduce HbA1c, body weight, and systolic blood pressure.
  • The study aims to confirm glycemic control achievement with dapagliflozin.
  • The research anticipates no adverse impact on cardiovascular risk.

Conclusions:

  • Dapagliflozin demonstrates potential for improving glycemic control in type 2 diabetes.
  • Further analysis is required to fully elucidate the cardiovascular benefits and safety profile.
  • The study protocol is registered in Research Registry (researchregistry5987).

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