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NCT Number: NCT03178591

Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

Type 2 diabetes mellitus (type 2 DM) is an important disease with increasing prevalence worldwide. More than 60% of diabetes patients die of CVD. Diabetes is associated with 2-to 4- fold increase in the risk of coronary artery disease (CAD). Diabetes patients with stable ischemic heart disease may have more prevalent of asymptomatic ischemia or silent ischemia due to autonomic neuropathy. Therefore, detection of total myocardial ischemia including both symptomatic and silent ischemia using ambulatory electrocardiogram monitoring may provide better accuracy in ischemic burden and prognosis in diabetes patients. DDP-4 inhibitors have favorable effects on atherosclerotic risk factors beyond glycemic control. Furthermore, DPP-4 inhibitors may have favorable effects on ischemic preconditioning in patients with CAD. For this study we aim to compare the effects of between vildagliptin and Dapagliflozin on ischemic burden defined by total ischemic time, markers of autonomic function, biomarkers of myocardial injury and biomarkers of inflammation.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Ischemic Heart Disease Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age > 21), male or non-child bearing potential female
  • Inadequately controlled type 2 diabetes with at least half maximum dose of metformin (HbA1C > 6.5 and < 9.0%)
  • Stable documented CAD defined as the followings:
  • Stable angina with > 70% stenosis of at least one major epicardial artery from coronary angiogram (CAG) or coronary CTA
  • Post myocardial infarction (> 30 days)

Exclusion criteria

  • Significant renal function (eGFR < 30ml/min)
  • Significant hepatic impairment or ALT/AST elevations beyond X2 upper normal limit or known hepatic failure
  • Planned coronary intervention or planed surgical intervention (PCI or CABG)
  • Recent (<30 day) acute coronary syndrome (ACS)
  • Hypersensitivity to either of the study drug components
  • History of lactic acidosis
  • Type 1 diabetes
  • Current HbA1c >9%
  • Current Insulin treatment
  • Active treatment with GLP-1 or other DPP4i medication
  • Inability to comply with study protocol
  • Active malignancy other than basal cell carcinoma
  • Clinically advanced congestive heart failure - NYHA III-IV
  • Severe left ventricular dysfunction (LVEF<25%)
  • Recent heart failure decompensation (<3 months)
  • Chronic inflammation (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)
  • Pregnancy, lactation or child-bearing potential

Treatment and study plan

Vildagliptin

Drug

Dapagliflozin

Drug

Primary outcomes

  1. Number of participants who has ST segment depression in ambulatory ECG monitoring during 24 hours at 6 months between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group

    Time frame: 6 months

  2. Number of myocardial dysfunction which verified by Exercise stress test at 6 month between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group

    Time frame: 6 months

  3. The event of autonomic dysfunction from heart rate variability, heart rate turbulence, QT interval at 6 month between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group

    Time frame: 6 months

  4. The myocardial injury event which verified by hsTnT level at 6 month between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group

    Time frame: 6 months

  5. The inflammation event which verified by hsCRP, IL-6 and TNF-alpha level at 6 month between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group

    Time frame: 6 months

  6. The oxidative stress event which verified by MDA and 8-isoprostaglandin F2 alpha level at 6 month between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group

    Time frame: 6 months

  7. The ventricular wall stretch event which verified by N-terminal ProBNP level between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group.

    Time frame: 6 months

  8. The average of systolic blood pressure at 6 month between DPP4 inhibitor (vildaglptin) group and SGLT2 inhibitors (Dapagliflozin) group.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor on Ischemic Burden in Stable Ischemic Heart Disease Patients

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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