NCT06649162

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Sep 2024Mar 2027

Study Start

First participant enrolled

September 30, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2.4 years

First QC Date

October 17, 2024

Last Update Submit

October 17, 2024

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    Baseline (visit 1)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 2 diabetes scheduled to administer a fixed-dose combination of dapagliflozin/pioglitazone

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Andong Hospital

Andong, Gyeongsangbuk-do, 36743, South Korea

RECRUITING

Konkuk University medical center

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Shin-young Oh

CONTACT

+82-2-708-8000syoh@boryung.co.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 18, 2024

Study Start

September 30, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)