A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02946541

Enrollment

160

Registered

2016-10-27

Start date

2013-07-31

Completion date

2015-04-30

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

DA-1229, evogliptin, DPP-IV inhibitor, Suganon, DPP-4 inhibitor

Brief summary

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.

Detailed 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.

Interventions

DRUGevogliptin 5mg

evogliptin 5mg, QD

DRUGPlacebo

Placebo, QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
HbA1c	Change from baseline at 24 weeks	unit: %

Secondary

Measure	Time frame	Description
fasting plasma glucose	Change from baseline at 24 weeks	unit: mg/dL
HbA1c response rate	Change from baseline at 24 weeks	unit: %

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026