NCT03011177

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

January 3, 2017

Last Update Submit

February 20, 2019

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    12week

Study Arms (2)

teneligliptin

EXPERIMENTAL

teneligliptin 20mg qd

Drug: Teneligliptin

linagliptin

ACTIVE COMPARATOR

linagliptin 5mg qd

Drug: Linagliptin

Interventions

TeneligliptinDRUG

teneligliptin 20mg qd

teneligliptin
LinagliptinDRUG

linagliptin 5mg qd

linagliptin

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidineLinagliptin

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 5, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

KR(1)