Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT03910361
Phase
PHASE4
Status
Completed

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
19 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Evogliptin — DRUG
    evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
  • Pioglitazone — DRUG
    pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd

Study Details

A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases

Key Dates

First listed
Apr 10, 2019
Start date
Apr 12, 2019
Status verified
Apr 2021
Primary completion
Jul 2, 2020
Completion
Jul 2, 2020

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evogliptin
    evogliptin 5mg
  • Active Comparator: Pioglitazone
    pioglitazone 15mg

Primary Outcome Measure

Changes from baseline intrahepatic fat (%) [ Time Frame: 24 weeks ]

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