NCT04446026

A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) prescribed with triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses (metformin \>= 1000mg/d, Glimepiride \>=4 mg/day, Gliclazide \>= 60 mg/day, SGLT-2 inhibitor with approved dose by Korea FDA) will be included. Using randomization, patients would take either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients who achieved a glycemic goal (HbA1c \<=7%) at 12th and 24th weeks will be evaluated.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	teneligliptin	teneligliptin 20mg PO qd for 24weeks
DRUG	Placebo	teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks

Timeline

• Start date: 2020-07-08
• Primary completion: 2020-12-07
• Completion: 2021-05-17
• First posted: 2020-06-24
• Last updated: 2021-06-09

Locations

1 site across 1 country: South Korea