Adding empagliflozin to alogliptin and metformin for type 2 diabetes
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin
Run by Celltrion · NCT07093476 · Data updated 2026-11-12
This study tests whether adding empagliflozin to adults already taking alogliptin and metformin improves blood sugar control and is safe for people with type 2 diabetes who still have high blood sugar.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 171 (estimated) |
| Sponsor | Celltrion Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | July 18, 2025 |
| Main results expected | December 2026 |
| Study ends | April 2027 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07093476 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with type 2 diabetes who are already taking metformin and alogliptin but still have insufficient glycemic control and can give informed consent are the intended participants.
✕Probably not a fit
People with non–type 2 diabetes, a history of hypersensitivity to the study drugs or drug classes, or uncontrolled severe diabetes complications are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 interventional trial testing empagliflozin as an add-on to background therapy with alogliptin and metformin in adults with type 2 diabetes who have inadequate glycemic control. Participants who meet eligibility will continue their alogliptin and metformin and receive empagliflozin as the investigational add-on therapy. The study will monitor changes in glycemic measures (such as HbA1c) and record adverse events to characterize safety. Outcomes will compare blood sugar control and tolerability while on the triple regimen.
Why it matters
Potential benefit: If successful, adding empagliflozin could lower blood sugar for patients not controlled on alogliptin plus metformin and may reduce diabetes-related risks.
How similar studies have gone: Prior large trials of empagliflozin and other SGLT2 inhibitors have shown improved glycemic control and cardiorenal benefits in many patients, supporting this add-on approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults at the time of signing the Informed Consent Form (ICF) * Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study * Diagnosed with T2DM Exclusion Criteria: * Diagnosed with other types of diabetes than T2DM * History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy * Uncontrolled severe complications of diabetes
Where it's running
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Celltrion
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Celltrion, Inc.
- Email: sanghee.byun@celltrion.com
- Phone: +82 3403 9647
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.