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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05281029

Enrollment

3000

Registered

2022-03-15

Start date

2021-06-24

Completion date

2023-10-31

Last updated

2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from Baseline of HbA1c at 24 weeks	Baseline, 24 weeks

Secondary

Measure	Time frame
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

Countries

South Korea

Contacts

Primary ContactStudy Lead

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

Outcome results