Back to resultsTenelia Elderly CGMS Study(TEDDY)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Teneligliptin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Patients who are 65 years or older on screening
- Patients with type 2 diabetes mellitus
- Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit
- Patients with FPG < 270mg/dL on screening visit
Exclusion Criteria:
-
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Teneligliptin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Change of HbA1c
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03508323
Brief Title
Tenelia Elderly CGMS Study(TEDDY)
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)
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
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
Detailed Description
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teneligliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Teneligliptin
Intervention Description
20mg/qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1T/qd
Primary Outcome Measure Information:
Title
HbA1c
Description
Change of HbA1c
Time Frame
after 12wks on baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are 65 years or older on screening
Patients with type 2 diabetes mellitus
Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit
Patients with FPG < 270mg/dL on screening visit
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JH Kim
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
34130378
Citation
Bae JC, Kwak SH, Kim HJ, Kim SY, Hwang YC, Suh S, Hyun BJ, Cha JE, Won JC, Kim JH. Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study). Diabetes Metab J. 2022 Jan;46(1):81-92. doi: 10.4093/dmj.2021.0016. Epub 2021 Jun 16.
Results Reference
derived
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Tenelia Elderly CGMS Study(TEDDY)
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