Tenelia Triple Combination Study

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Teneligliptin

• Registration Number: NCT02567994
• Lead Sponsor: Handok Inc.

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Teneligliptin	100mg qd
Teneligliptin	Teneligliptin	20mg qd

Primary Outcome Measures

Name	Time	Method
Change of HbAlc from baseline at Week 24	24 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of