Identifying NAFLD risk in type 2 diabetes patients and evaluating a medication combination
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
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Andong, Gyeongsangbuk-do and 1 other locations) |
| Trial ID | NCT06649162 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Andong, Gyeongsangbuk-do and 1 other locations
- 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
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.