Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin
- Conditions
- Type2 Diabetes
- Sponsor
- Wonju Severance Christian Hospital
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardiovascular and renal protection in patients with type 2 diabetes (T2D); however, the underlying mechanism remains unclear. We hypothesized that SGLT2 inhibitor will improve the ketone metabolism compared to dipeptidyl Peptidase-4 (DPP4) inhibitor. And we will also evaluate the association between ketone metabolism and cardiac remodeling evaluated by echocardiography. We will randomly assign 122 people with T2DM to receive dapagliflozin 10mg or gemigliptin 50mg. The primary endpoint are changes in acetoacetate, total ketone, beta-hydroxybutyric acid, left ventricular (LV) mass index, and LV global longitudinal strain during 6 months follow-up. This study may provide robust evidence of the thrifty substrate hypothesis for cardiovascular protection of SGLT2 inhibitors.
Investigators
Dong-Hyuk Cho
Assistant Professor
Wonju Severance Christian Hospital
Eligibility Criteria
Inclusion Criteria
- •Subjects diagnosed with T2D on stable antidiabetic medication
- •No recent use of SGLT2 inhibitor within 3 months
Exclusion Criteria
- •HbA1c \> 10%
- •Pregnancy or breast feeding
- •estimated GFR \<45 30 mL/min/1.73㎡
- •insulin user
Arms & Interventions
Dapagliflozin group
Dapagliflozin 10mg for 6 months.
Intervention: Dapagliflozin
Gemigliptin group
Gemigliptin 50mg for 6 months.
Intervention: Gemigliptin
Outcomes
Primary Outcomes
Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
Time Frame: 6 months
The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
Change (%) in LV mass index
Time Frame: 6 months
The change of LV mass index from baseline to 6 months follow-up
Secondary Outcomes
- Change (%) in LV ejection global longitudinal strain(6 months)
- Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure(6 months)