Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients (TELIUS)

February 20, 2019 updated by: Handok Inc.

A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: teneligliptin
teneligliptin 20mg qd
Drug: Teneligliptin
teneligliptin 20mg qd
ACTIVE_COMPARATOR: linagliptin
linagliptin 5mg qd
Drug: Linagliptin
linagliptin 5mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 12week
12week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (ESTIMATE)

January 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP_C402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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