Comparing blood sugar swings with different diabetes pill combinations in type 2 diabetes
A Multicenter Study to Evaluate Efficacy and Safety
This study will test whether different combinations of empagliflozin, metformin, linagliptin, or anagliptin reduce blood sugar swings in adults with type 2 diabetes who remain uncontrolled on metformin plus an SGLT2 inhibitor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | JW Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07442006 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, phase 4, interventional trial comparing several combination oral regimens in people with type 2 diabetes who have inadequate control on metformin and an SGLT2 inhibitor. Participants will be assigned to treatment arms that include combinations such as empagliflozin/metformin, empagliflozin/linagliptin, anagliptin, or metformin alone to observe effects on glycemic variability. Continuous glucose monitoring and routine safety labs will be used to measure day-to-day glucose fluctuations and adverse events. The trial focuses on both efficacy for reducing variability and the safety profile in a real-world treatment setting.
Who should consider this trial
Good fit: Adults with type 2 diabetes who have inadequate glycemic control despite taking metformin (≥1,000 mg/day) plus an SGLT2 inhibitor, and who do not have significant renal, hepatic, or advanced heart failure, are ideal candidates.
Not a fit: People with moderate-to-severe renal impairment (eGFR <45 mL/min/1.73m²), severe hepatic impairment, a history of metabolic acidosis, or NYHA class III/IV heart failure are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, it could identify combination regimens that reduce glucose variability and improve day-to-day blood sugar control while maintaining acceptable safety.
How similar studies have performed: Previous trials of SGLT2 plus DPP-4 inhibitor or metformin combinations have demonstrated improvements in HbA1c and some reductions in glycemic variability, so this approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor. Exclusion Criteria: * History of acute or chronic metabolic acidosis * Moderate to severe renal impairment (eGFR \< 45 mL/min/1.73m²) * Severe hepatic impairment * History of heart failure (NYHA Class III/IV)
Where this trial is running
Seoul
- The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Sung Rae Kim — The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
- Study coordinator: Saemi Kang
- Email: kangsm@jwhealthcare.com
- Phone: 82-2-840-6902
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.