Observational Study Gemigliptin in Patients Aged ≥ 65 Yea... | NCT05281029

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

NCT05281029

Sponsor

LG Chem

Status

Unknown status

Last Update Posted

Mar 16, 2022Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2021Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Mar 6, 2022

First Submission Date that Met QC Criteria

Mar 6, 2022

First Posted Date

Mar 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2022

Last Update Posted Date

Mar 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline of HbA1c at 24 weeks		Baseline, 24 weeks

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Primary care clinic, secondary and tertiary hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Lead	Contact	+82-2-3777-1114		jihyun.heo@lgchem.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided