A Phase 4 interventional study of Dapagliflozin and Gemigliptin in Type2 Diabetes and Remodeling, Ventricular, sponsored by Wonju Severance Christian Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Wonju Severance Christian Hospital · Phase 4, Interventional, and Treatment
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.
105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.
This study's planned enrollment of 122 is above the median of 81 across 72 interventional studies indexed under Ventricular Remodeling.
Browse Ventricular Remodeling studies →Wonju Severance Christian Hospital is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dapagliflozin 10mg for 6 months.
Drug: Dapagliflozin
Gemigliptin 50mg for 6 months.
Drug: Gemigliptin
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.
Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
Time frame: 6 months
Change (%) in LV mass index
The change of LV mass index from baseline to 6 months follow-up
Time frame: 6 months
Change (%) in LV ejection global longitudinal strain
The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up
Time frame: 6 months
Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure
The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up
Time frame: 6 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapagliflozin
Wonju Severance Christian Hospital