Identifying NAFLD risk in type 2 diabetes patients and evaluating a medication combination
Official title: A Multi-center, Prospective, Cohort Study to Identify the Risk of Non-alcoholic Fatty Liver Disease (NAFLD) in Patients With Type 2 Diabetes in Clinical Practice and to Evaluate the Clinical Usefulness of Dapagliflozin/Pioglitazone Combination Therapy
Run by Boryung Pharmaceutical Co., Ltd · NCT06649162 · Data updated 2026-11-12
This study is testing whether a combination of two diabetes medications can help people with type 2 diabetes reduce their risk of developing non-alcoholic fatty liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Andong, Gyeongsangbuk-do and 1 other locations) |
| Status | Recruiting |
| Started | September 30, 2024 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | October 18, 2024 |
| Trial ID | NCT06649162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with type 2 diabetes who are about to start treatment with a fixed-dose combination of dapagliflozin and pioglitazone.
✕Probably not a fit
Patients who have previously taken the dapagliflozin/pioglitazone combination or those who will require insulin during the study may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the risk of non-alcoholic fatty liver disease (NAFLD) in patients diagnosed with type 2 diabetes in a clinical setting. It will also evaluate the effectiveness of a combination therapy using dapagliflozin and pioglitazone. The study will involve patients who are scheduled to receive this fixed-dose combination therapy and will collect data on their health outcomes. Participants will provide informed consent before joining the study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with type 2 diabetes at risk of NAFLD.
How similar studies have gone: While there is ongoing research into the effects of dapagliflozin and pioglitazone, this specific combination therapy for NAFLD risk assessment in type 2 diabetes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Among patients with type 2 diabetes, those who are scheduled to administer a fixed-dose combination of dapagliflozin/pioglitazone at baseline (visit 1) * Those who voluntarily signed a written personal information collection and usage agreement after listening to an explanation about the objective and method, etc. of this clinical study. Exclusion Criteria: * Those who have a history of taking a fixed-dose combination of dapagliflozin/pioglitazone at baseline (visit 1). * Those who are expected to need insulin prescription during the study period.
Where it's running
-
Andong Hospital
Andong, Gyeongsangbuk-do, South Korea Recruiting -
Konkuk University medical center
Seoul, South Korea Not yet recruiting
Study contacts
- Study coordinator: Shin-young Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
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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.