Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes

Phase 4

Recruiting

• Conditions: Type2 Diabetes; Remodeling, Ventricular
• Interventions: Drug: Gemigliptin; Drug: Dapagliflozin

• Registration Number: NCT05194592
• Lead Sponsor: Wonju Severance Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-04
• Study Start: 2022-01-07
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemigliptin group	Gemigliptin	Gemigliptin 50mg for 6 months.
Dapagliflozin group	Dapagliflozin	Dapagliflozin 10mg for 6 months.

Primary Outcome Measures

Name	Time	Method
Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid	6 months	The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
Change (%) in LV mass index	6 months	The change of LV mass index from baseline to 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Change (%) in LV ejection global longitudinal strain	6 months	The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up
Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure	6 months	The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up

Trial Locations

Locations (1)

Yonsei University Wonju College of Medicine; 🇰🇷 Wonju, Gangwondo, Korea, Republic of