Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

NCT ID: NCT03011177

Last Updated: 2019-02-22

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

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-09-30

Brief Summary

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To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.

Detailed Description

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A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

Conditions

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Type2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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teneligliptin

teneligliptin 20mg qd

Group Type EXPERIMENTAL

Teneligliptin

Intervention Type DRUG

teneligliptin 20mg qd

linagliptin

linagliptin 5mg qd

Group Type ACTIVE_COMPARATOR

Linagliptin

Intervention Type DRUG

linagliptin 5mg qd

Interventions

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Teneligliptin

teneligliptin 20mg qd

Intervention Type DRUG

Linagliptin

linagliptin 5mg qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are 19 years or older on screening
* Patients with type 2 diabetes mellitus
* Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
* Patients with Fasting Plasma Glucose \<15mmol/L(270mg/dL) on screening

Exclusion Criteria

\-
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MP_C402

Identifier Type: -

Identifier Source: org_study_id

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