Observational Study Gemigliptin in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
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
1 other identifier
observational
3,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2021
CompletedFirst Submitted
Initial submission to the registry
March 6, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedMarch 16, 2022
March 1, 2022
2.4 years
March 6, 2022
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline of HbA1c at 24 weeks
Baseline, 24 weeks
Secondary Outcomes (2)
Change from Baseline of HbA1c at 12 weeks
Baseline, 12 weeks
The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c.
24 weeks
Eligibility Criteria
Primary care clinic, secondary and tertiary hospital
You may qualify if:
- Patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form
You may not qualify if:
- Patients with previous exposure to gemigliptin and current participation in clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
Study Sites (1)
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2022
First Posted
March 15, 2022
Study Start
June 24, 2021
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
March 16, 2022
Record last verified: 2022-03