CClinicalTrials.gg
Status unknownNCT05281029Updated Mar 16, 2022

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

An observational study in Type 2 Diabetes Mellitus, sponsored by LG Chem. Status unknown at 1 site in Korea, Republic of. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by LG Chem · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
65 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic, secondary and tertiary hospital

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

Exclusion Criteria:

  • Patients with previous exposure to gemigliptin and current participation in clinical trials
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change from Baseline of HbA1c at 24 weeks

    Time frame: Baseline, 24 weeks

Secondary outcomes

  1. Change from Baseline of HbA1c at 12 weeks

    Time frame: Baseline, 12 weeks

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

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Severance Hospital
    Seoul, Korea, Republic of
    • Severance Hospital · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05281029
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Mar 15, 2022
Start date
Jun 24, 2021
Primary completion
Oct 31, 2023 (estimated)
Completion
Oct 31, 2023 (estimated)
Last update
Mar 16, 2022

Study contacts

Study Lead
Contact
jihyun.heo@lgchem.com
+82-2-3777-1114

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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