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

Wonju Severance Christian Hospital

Status and phase: Enrolling; Phase 4

Conditions: Remodeling, Ventricular; Type2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Gemigliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT05194592

CR121038

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups, including a placebo group

Dapagliflozin group

Active Comparator group

Description:

Dapagliflozin 10mg for 6 months.

Treatment:

Drug: Dapagliflozin

Gemigliptin group

Placebo Comparator group

Description:

Gemigliptin 50mg for 6 months.

Treatment:

Drug: Gemigliptin