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

August 16, 2022 updated by: Handok Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teneligliptin 20 mg
Once daily for 24 weeks
Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
To be orally administered once daily
Placebo Comparator: Teneligliptin placebo
Once daily for 24 weeks
Drug: Teneligliptin Placebo Oral Tablet
To be orally administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline HbA1c at week 24
Time Frame: Baseline (week 0) and week 24
Baseline (week 0) and week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-MP-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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