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CompletedNCT03011177TELIUSUpdated Feb 22, 2019

Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

A Phase 4 interventional study of Teneligliptin and Linagliptin in Type2 Diabetes Mellitus, sponsored by Handok Inc.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by Handok Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Type2 Diabetes Mellitus
03

In context

Lead sponsor

Handok Inc. is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    teneligliptin

    teneligliptin 20mg qd

    Drug: Teneligliptin

  • Active comparator
    linagliptin

    linagliptin 5mg qd

    Drug: Linagliptin

Interventions

06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: 12week

07

Study locations

1 site
  • Asan Medical Center
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Sep 2018, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2017
First posted
Jan 5, 2017
StartActual
Jan 2017
Primary completionActual
Sep 2018
CompletionActual
Sep 2018
Last update
Feb 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03011177
Lead sponsor
Handok Inc.
Responsible party
Sponsor
First posted
Jan 5, 2017
Start date
Jan 2017
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Feb 22, 2019
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Teneligliptin

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