A 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The purpose of this study is 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
Primary outcome measures
- Percentage of subjects who correspond to high risk score (≥8) by evaluating simple NAFLD score [Time frame: Baseline (visit 1)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 2 centers
- Andong Hospital — Andong
- Konkuk University medical center — Seoul
Identifiers
NCT: NCT06649162 · BR-DPC-OS-401