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
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Faculty of Medicine, Chiang Mai University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
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
No
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
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Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor
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