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

Type 2 Diabetes Clinical Trial

— TERA 305  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504226
• Other study ID #: HD-MP-305
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2022
• Source: Handok Inc.
• Contact: SeJin Kim
• Phone: 82-2-527-5364
• Email: sejin.kim[@]handok.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: May 31, 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with Type II diabetes mellitus aged 19 years or older
• Subjects with 7.0%=HbA1c=10.5% at screening visit
• Subjects with fasting plasma glucose = 270mg/dL at screening visit

Exclusion Criteria:

• Subjects with type 1 diabetes mellitus or secondary diabetes
• Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
• Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
• Body mass index greater than 40 kg/m2 at the screening visit
• Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
To be orally administered once daily
• Teneligliptin Placebo Oral Tablet
To be orally administered once daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline HbA1c at week 24		Baseline (week 0) and week 24
Secondary	Changes from baseline FPG at week 24		Baseline (week 0) and week 24
Secondary	Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24		Baseline (week 0) and week 24
Secondary	Changes from baseline in BMI at week 24		Baseline (week 0) and week 24