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Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

Primary Purpose

Diabetes Mellitus, Type 2, Ischemic Heart Disease

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

vildagliptin

Dapagliflozin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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:

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

Sites / Locations

Faculty of Medicine, Chiang Mai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

vildagliptin

Dapagliflozin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03178591

First Posted

January 9, 2017

Last Updated

July 17, 2018

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT03178591

Brief Title

Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiang Mai University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Ischemic Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vildagliptin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dapagliflozin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arintaya Phrommintikul, MD

Organizational Affiliation

Faculty of Medicine, Chiang Mai University

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Medicine, Chiang Mai University

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

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