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To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes

NCT03950505 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-09

No results posted yet for this study

Summary

This study was designed to evaluate the effect of Nesinaact on non-alcoholic steatohepatitis through magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) and liver fibroscan in patients with type 2 diabetes. This is a prospective, open-label, single-arm, single-center clinical Study. After 24 weeks of Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment, the improvement of parameters estimated by MRI and liver fibroscan will be estimated.

Conditions

  • Non-alcoholic Steatohepatitis
  • Type2 Diabetes

Interventions

DRUG

Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks

All participants will be treated with Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) for 24 weeks. Patients who have not been prescribed any other anti-diabetic drugs at least for 12 weeks and whose HbA1c ranges from 6.5\~8.5%, can be enrolled. If Patients has been prescribed metformin as monotherapy, they have to substitute metformin with nesinaact 25-15 for enrollment.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03950505 on ClinicalTrials.gov