Tenelia Triple Combination Study (TETRIS)

Handok

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Teneligliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02567994

MP_C303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 2 patient groups

Teneligliptin

Experimental group

Description:

20mg qd

Treatment:

Drug: Teneligliptin

Sitagliptin

Active Comparator group

Description:

100mg qd

Treatment:

Drug: Teneligliptin