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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05281029
Other study ID # LG-DPOS002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2021
Est. completion date October 31, 2023

Study information

Verified date March 2022
Source LG Chem
Contact Study Lead
Phone +82-2-3777-1114
Email jihyun.heo@lgchem.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline of HbA1c at 24 weeks Baseline, 24 weeks
Secondary Change from Baseline of HbA1c at 12 weeks Baseline, 12 weeks
Secondary The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c. 24 weeks
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