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

Primary Purpose

Type2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Teneligliptin
Linagliptin
Sponsored by
Handok Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

teneligliptin

linagliptin

Arm Description

teneligliptin 20mg qd

linagliptin 5mg qd

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Full Information

First Posted
January 3, 2017
Last Updated
February 20, 2019
Sponsor
Handok Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03011177
Brief Title
Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients
Acronym
TELIUS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Handok Inc.

4. Oversight

5. Study Description

Brief Summary
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.
Detailed Description
A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
teneligliptin
Arm Type
Experimental
Arm Description
teneligliptin 20mg qd
Arm Title
linagliptin
Arm Type
Active Comparator
Arm Description
linagliptin 5mg qd
Intervention Type
Drug
Intervention Name(s)
Teneligliptin
Intervention Description
teneligliptin 20mg qd
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
linagliptin 5mg qd
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
12week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

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