NCT05194592

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Wonju Severance Christian Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes
• Remodeling, Ventricular

Interventions

Type	Name	Description
DRUG	Dapagliflozin	The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
DRUG	Gemigliptin	The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.

Timeline

• Start date: 2022-01-07
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2022-01-18
• Last updated: 2023-08-01

Locations

1 site across 1 country: South Korea