Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02949193

Enrollment

222

Registered

2016-10-31

Start date

2013-05-31

Completion date

2015-05-31

Last updated

2016-10-31

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

Conditions

Type 2 Diabetes Mellitus

Brief summary

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Detailed description

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks. 2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Interventions

DRUGevogliptin

evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg

DRUGSitagliptin

sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

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≤11.0% at screening * Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening * 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 week	unit: %

Secondary

Measure	Time frame	Description
fasting plasma glucose	Change from baseline at 24 week	unit : mg/dL
HOMA-beta	Change from baseline at 24 week	unit: %
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