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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet; Drug: Teneligliptin Placebo Oral Tablet

• Registration Number: NCT05504239
• Lead Sponsor: Handok Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2022-09-27
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teneligliptin 20 mg	Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet	Once daily for 24 weeks
Teneligliptin placebo	Teneligliptin Placebo Oral Tablet	Once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Changes from baseline HbA1c at week 24	Baseline (week 0) and week 24

Secondary Outcome Measures

Name	Time	Method
Changes from baseline FPG at week 24	Baseline (week 0) and week 24
Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24	Baseline (week 0) and week 24
Changes from baseline in BMI at week 24	Baseline (week 0) and week 24

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of