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NCT Number: NCT03910361

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

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

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Key information

Conditions

Type2 Diabetes Digestive System Diseases Fatty Liver Liver Diseases Non-Alcoholic Fatty Liver Disease

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center, Changwon, South Korea

Loading trial locations.

About this study

  • Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
  • Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type II diabetes mellitus
  • Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
  • Subjects with 6.5%≤HbA1c≤9.0% at screening
  • Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion criteria

  • Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
  • AST > upper normal range*3
  • Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
  • Pregnant women

Treatment and study plan

Evogliptin

Drug

evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd

Other names: Suganon

pioglitazone

Drug

pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd

Other names: Gluconon

Primary outcomes

  1. Changes from baseline intrahepatic fat (%)

    Time frame: 24 weeks

    Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2019
Registry last updated
Apr 29, 2021

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.

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