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

NCT ID: NCT02949193

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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evogliptin

evogliptin 5mg qd add-on to metformin

Group Type EXPERIMENTAL

evogliptin

Intervention Type DRUG

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

sitagliptin

sitagliptin 100mg qd add-on to metformin

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

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

Interventions

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evogliptin

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

Intervention Type DRUG

Sitagliptin

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

Intervention Type DRUG

Other Intervention Names

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Suganon januvia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sung Woo Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Kangbuk Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_DMC_III

Identifier Type: -

Identifier Source: org_study_id