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Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

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ClinicalTrials.gov Identifier: NCT03178591
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Arintaya Phrommintikul, Chiang Mai University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Ischemic Heart Disease Drug: vildagliptin Drug: Dapagliflozin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor on Ischemic Burden in Stable Ischemic Heart Disease Patients
Actual Study Start Date : October 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

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Arm Intervention/treatment
Active Comparator: vildagliptin
Vildagliptin is a dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor) Dose of Vildagliptin is 50 mg once or twice daily.
Drug: vildagliptin
Active Comparator: Dapagliflozin
Dapagliflozin is a sodium glucose cotransporter-2 (SGLT-2 inhibitor) Dose of Dapagliflozin is 10 mg once daily.
Drug: Dapagliflozin



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (age > 21), male or non-child bearing potential female
  2. Inadequately controlled type 2 diabetes with at least half maximum dose of metformin (HbA1C > 6.5 and < 9.0%)
  3. Stable documented CAD defined as the followings:

    1. Stable angina with > 70% stenosis of at least one major epicardial artery from coronary angiogram (CAG) or coronary CTA
    2. Post myocardial infarction (> 30 days)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178591


Locations
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Thailand
Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Study Chair: Arintaya Phrommintikul, MD Faculty of Medicine, Chiang Mai University

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Responsible Party: Arintaya Phrommintikul, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03178591     History of Changes
Other Study ID Numbers: MED-2559-04116
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Diabetes Mellitus, Type 2
Ischemia
Pathologic Processes
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors