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Observational Study Gemigliptin in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus

Sponsor
LG Chem (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05281029
Collaborator
(none)
3,000
Enrollment
1
Location
28.2
Anticipated Duration (Months)
106.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multicenter, Single-arm, Prospective Observational Study to Evaluate the Safety and Effectiveness of Gemigliptin (as Monotherapy or as Single Pill Combinations) in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
    Actual Study Start Date :
    Jun 24, 2021
    Anticipated Primary Completion Date :
    Oct 31, 2023
    Anticipated Study Completion Date :
    Oct 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline of HbA1c at 24 weeks [Baseline, 24 weeks]

    Secondary Outcome Measures

    1. Change from Baseline of HbA1c at 12 weeks [Baseline, 12 weeks]

    2. The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c. [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form
    Exclusion Criteria:
    • Patients with previous exposure to gemigliptin and current participation in clinical trials

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • LG Chem

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LG Chem
    ClinicalTrials.gov Identifier:
    NCT05281029
    Other Study ID Numbers:
    • LG-DPOS002
    First Posted:
    Mar 15, 2022
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Mar 16, 2022