NCT05663736

Brief Summary

Among DPP-4 inhibitors, gemigliptin is a relatively recently developed drug, and many clinical studies have shown results that are equivalent to or superior to existing DPP-4 inhibitors such as sitagliptin. However, studies on the safety of gemigliptin in cardiovascular disease have not been conducted, and studies on its effect on cardiac function are lacking. Considering the increase in hospitalizations due to heart failure found in some DPP-4 inhibitor studies, investigation of directly effect of gemigliptin on heart function would be clinically important.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

December 15, 2022

Last Update Submit

March 6, 2023

Conditions

Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycated hemoglobin

    24 weeks

Secondary Outcomes (10)

  • Ejection fraction

    24 weeks

  • E/e'

    24 weeks

  • LV mass index

    24 weeks

  • LV end-diastolic volumn

    24 weeks

  • NT-proBNP

    24 weeks

  • +5 more secondary outcomes

Study Arms (2)

Gemiglipitin

EXPERIMENTAL

A DPP4 inhibitor gemigliptin treatment group

Drug: Gemigliptin

Glimepiride

ACTIVE COMPARATOR

A sulfonylurea glimepiride treatment group

Drug: Glimepiride

Interventions

GemigliptinDRUG

DPP-4 inhibitor

Also known as: Zemiglo
Gemiglipitin
GlimepirideDRUG

Glimepiride

Glimepiride

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with type 2 diabetes were eligible if they were aged \>20 years, had received metformin (500 mg - 2550 mg) alone for more than 6 weeks and have a glycated hemoglobin of 7%-9.5%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Interventions

LC15-0444glimepiride

Study Officials

  • Soo Lim, MD

    SNUBH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Lim, MD

CONTACT

01097662706limsoo@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2022

First Posted

December 23, 2022

Study Start

January 1, 2020

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)