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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Type2 Diabetes; Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Pioglitazone; Drug: Evogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03910361

DA1229_NAFLD_IV

Details and patient eligibility

About

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

Full 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

Enrollment: 51 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups

Evogliptin

Experimental group

Description:

evogliptin 5mg

Treatment:

Drug: Evogliptin

Pioglitazone

Active Comparator group

Description:

pioglitazone 15mg

Treatment:

Drug: Pioglitazone