Comparing Dapagliflozin and Gemigliptin for Heart Health in Type 2 Diabetes
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
This study is testing whether two diabetes medications, dapagliflozin and gemigliptin, can improve heart health in people with type 2 diabetes over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Wonju Severance Christian Hospital Academic / other |
| Locations | 1 site (Wonju, Gangwondo) |
| Trial ID | NCT05194592 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two medications, dapagliflozin and gemigliptin, on ketone metabolism and cardiac remodeling in patients with type 2 diabetes. A total of 122 participants will be randomly assigned to receive either dapagliflozin 10mg or gemigliptin 50mg for a duration of six months. The study aims to measure changes in specific ketone levels and heart function indicators, providing insights into the cardiovascular benefits of SGLT2 inhibitors. The findings may help clarify the mechanisms behind the protective effects of these medications on heart health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 2 diabetes who are on stable antidiabetic medication and have not used SGLT2 inhibitors in the past three months.
Not a fit: Patients with an HbA1c greater than 10%, those who are pregnant or breastfeeding, individuals with significantly reduced kidney function, or insulin users may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how certain diabetes medications improve heart health, potentially leading to better treatment options for patients.
How similar studies have performed: Other studies have shown promising results with SGLT2 inhibitors in improving cardiovascular outcomes, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wonju, Gangwondo
- Yonsei University Wonju College of Medicine — Wonju, Gangwondo, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Dong-Hyuk Cho, MD,PhD
- Email: why012@gmail.com
- Phone: 82-33-741-0916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.