NCT03508323

Brief Summary

To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

April 16, 2018

Last Update Submit

June 28, 2022

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change of HbA1c

    after 12wks on baseline

Study Arms (2)

Teneligliptin

EXPERIMENTAL
Drug: Teneligliptin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TeneligliptinDRUG

20mg/qd

Teneligliptin
PlaceboDRUG

1T/qd

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34130378DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • JH Kim

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

April 3, 2018

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

KR(1)