Phase 3Completed

Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin (TERA 305)

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

Sponsor: Handok Inc. (Industry)
Enrolment: 214 enrolled
Conditions: Type 2 Diabetes
Interventions: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet; Teneligliptin Placebo Oral Tablet
Ages: adults, older adults
Registry: NCT05504226

From the registry

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

Primary outcomes

Changes from baseline HbA1c at week 24

Full record on ClinicalTrials.gov

Papers citing this trial

A 52-Week Efficacy and Safety Study of Teneligliptin, as an Add-On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial (TERA305 Study)
Diabetes, obesity & metabolism