NCT02567994

Tenelia Triple Combination Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-10-05
• Last updated: 2018-05-02

Locations

1 site across 1 country: South Korea