A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: evogliptin 5mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02946541

DA1229_DMM_III

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

evogliptin 5mg

Experimental group

Description:

evogliptin 5mg QD

Treatment:

Drug: evogliptin 5mg

placebo

Placebo Comparator group

Description:

Placebo QD

Treatment:

Drug: Placebo