TETRIS: Tenelia Triple Combination Study

Sponsor

Handok Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02567994

Collaborator

(none)

201

Enrollment

Location

Arms

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Teneligliptin	Phase 3

Detailed Description

Subjects will visit the centers on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.

Study Design

Study Type:

Interventional

Actual Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Teneligliptin Versus Sitagliptin as add-on Therapy to Metformin Plus Glimepiride in T2DM Patinets With Inadequate Glycemic Control

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teneligliptin 20mg qd	Drug: Teneligliptin Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.
Active Comparator: Sitagliptin 100mg qd	Drug: Teneligliptin Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.

Arm

Intervention/Treatment

Experimental: Teneligliptin

20mg qd

Drug: Teneligliptin

Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.

Active Comparator: Sitagliptin

100mg qd

Drug: Teneligliptin

Outcome Measures

Primary Outcome Measures

Change of HbAlc from baseline at Week 24 [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Type 2 Diabetes Mellitus
Adults aged ≥ 19 years old
Patients with HbA1c 7%~11% at Screening and Run-in visit

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Handok Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Handok Inc.

ClinicalTrials.gov Identifier:

NCT02567994

Other Study ID Numbers:

MP_C303

First Posted:

Oct 5, 2015

Last Update Posted:

May 2, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 2, 2018