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

Sponsor
Wonju Severance Christian Hospital
Study ID
NCT05194592
Phase
PHASE4
Status
Unknown

Conditions

  • Remodeling, Ventricular
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 7, 2022
Status verified
Jul 2023
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin group
    Dapagliflozin 10mg for 6 months.
  • Placebo Comparator: Gemigliptin group
    Gemigliptin 50mg for 6 months.

Primary Outcome Measure

Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid [ Time Frame: 6 months ]

Central Contacts

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