NCT05504239

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (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 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
DRUG	Teneligliptin Placebo Oral Tablet	To be orally administered once daily

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2022-08-17
• Last updated: 2025-01-24

Locations

1 site across 1 country: South Korea