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OpenTrials
Completed

NCT Number: NCT05504226

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet

Drug

To be orally administered once daily for 52 weeks.

Teneligliptin Placebo Oral Tablet

Drug

To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.

Primary outcomes

  1. Changes from baseline HbA1c at week 24

    Time frame: Baseline (week 0) and week 24

Secondary outcomes

  1. Changes from baseline FPG at week 24

    Time frame: Baseline (week 0) and week 24

  2. Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24

    Time frame: Baseline (week 0) and week 24

  3. Changes from baseline in BMI at week 24

    Time frame: Baseline (week 0) and week 24

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study 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

Acronym: TERA 305

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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