NCT05504226

Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin

A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet	To be orally administered once daily for 52 weeks.
DRUG	Teneligliptin Placebo Oral Tablet	To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-11-30
• Completion: 2024-06-18
• First posted: 2022-08-17
• Last updated: 2025-01-27

Locations

1 site across 1 country: South Korea