Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

NCT ID: NCT03178591

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-07-31

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.

Conditions

Diabetes Mellitus, Type 2; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vildagliptin

Vildagliptin is a dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor) Dose of Vildagliptin is 50 mg once or twice daily.

Group Type: ACTIVE_COMPARATOR

vildagliptin

Intervention Type: DRUG

Dapagliflozin

Dapagliflozin is a sodium glucose cotransporter-2 (SGLT-2 inhibitor) Dose of Dapagliflozin is 10 mg once daily.

Group Type: ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type: DRUG

Interventions

vildagliptin

Intervention Type: DRUG

Dapagliflozin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Arintaya Phrommintikul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arintaya Phrommintikul, MD

Role: STUDY_CHAIR

Faculty of Medicine, Chiang Mai University

Locations

Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

Countries

Thailand

Other Identifiers

MED-2559-04116

Identifier Type: -

Identifier Source: org_study_id