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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andong Hospital, Andong, Gyeongsangbuk-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Percentage of subjects who correspond to high risk score (≥8) by evaluating simple NAFLD score

Time frame: Baseline (visit 1)

Study contacts

Contact information is provided by the study sponsor or research team.

Shin-young Oh

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Oct 18, 2024
Registry last updated: Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting