A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

Dong-A ST Co., Ltd.160 enrolled

Overview

This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks. 2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Type 2 Diabetes Mellitus

Interventions

evogliptin 5mgDRUG

evogliptin 5mg, QD

PlaceboDRUG

Placebo, QD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with 6.5%≤HbA1c≤10.0% at screening * Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening * Subjects with 6.5%≤HbA1c≤10.0% at Visit 2 * Subjects with 20kg/m2≤BMI≤40kg/m2 at screening Exclusion Criteria: * Subjects with fasting plasma glucose≥270mg/dL at screening * Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus * Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening * Subjects with ALT and AST 2.5 times or higher than upper normal range

Locations (1)

Kangdong Sacred Heart Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

HbA1c

unit: %

Time frame: Change from baseline at 24 weeks

Secondary Outcomes

fasting plasma glucose

unit: mg/dL

Time frame: Change from baseline at 24 weeks

HbA1c response rate

unit: %

Time frame: Change from baseline at 24 weeks

Data from ClinicalTrials.gov

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