Type2 Diabetes, Non-Alcoholic Fatty Liver Disease
Conditions
Brief summary
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
Detailed description
1. Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks 2. Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
Interventions
DRUGEvogliptin
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
DRUGPioglitazone
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline intrahepatic fat (%) | 24 weeks | Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone |
Countries
South Korea
Outcome results
None listed