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CompletedNCT03178591Updated Jul 19, 2018

Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

A Phase 4 interventional study of vildagliptin and Dapagliflozin in Diabetes Mellitus, Type 2 and Ischemic Heart Disease, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Chiang Mai University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Oct 2014, registered Jan 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Ischemic Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • 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

Interventions

  • Drugvildagliptin
  • DrugDapagliflozin
06

What researchers measure

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

07

Study locations

1 site
  • Faculty of Medicine, Chiang Mai University
    Chiang Mai, 50200, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03178591
Lead sponsor
Chiang Mai University
Responsible party
Arintaya Phrommintikul (Associate Professor, Chiang Mai University) — Principal investigator
First posted
Jun 7, 2017
Start date
Oct 2014
Primary completion
Jul 2018
Completion
Jul 2018
Last update
Jul 19, 2018

Study contacts

Arintaya Phrommintikul, MD
study chair · Faculty of Medicine, Chiang Mai University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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