Back to resultsClinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin (TERA 305)
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
Teneligliptin Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Teneligliptin 20 mg
Teneligliptin placebo
Arm Description
Once daily for 24 weeks
Once daily for 24 weeks
Outcomes
Primary Outcome Measures
Changes from baseline HbA1c at week 24
Secondary Outcome Measures
Changes from baseline FPG at week 24
Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
Changes from baseline in BMI at week 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05504226
Brief Title
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Handok Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 25 mg and metformin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teneligliptin 20 mg
Arm Type
Experimental
Arm Description
Once daily for 24 weeks
Arm Title
Teneligliptin placebo
Arm Type
Placebo Comparator
Arm Description
Once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
Intervention Description
To be orally administered once daily
Intervention Type
Drug
Intervention Name(s)
Teneligliptin Placebo Oral Tablet
Intervention Description
To be orally administered once daily
Primary Outcome Measure Information:
Title
Changes from baseline HbA1c at week 24
Time Frame
Baseline (week 0) and week 24
Secondary Outcome Measure Information:
Title
Changes from baseline FPG at week 24
Time Frame
Baseline (week 0) and week 24
Title
Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
Time Frame
Baseline (week 0) and week 24
Title
Changes from baseline in BMI at week 24
Time Frame
Baseline (week 0) and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SeJin Kim
Phone
82-2-527-5364
Email
sejin.kim@handok.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KS Park, Ph.D
Phone
+82-2-2072-2946
Email
kspark@snu.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
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