NCT06495281

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,044

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 26, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

July 2, 2024

Last Update Submit

March 8, 2026

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • change from baseline of HbA1c at 12 weeks

    baseline, 12 weeks

Secondary Outcomes (1)

  • the rate of subjects who reached the target value of less than 7% HbA1c

    12 weeks

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic, secondary and tetiary hospital

You may qualify if:

  • type 2 DM Patients who are receiving one of the following three therapies during which the patients are prescribed with Zemidapa Tab. for the first time at the discretion of the attending physician:
  • Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin)
  • Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor)
  • Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and Sulfonylurea \[SU\])
  • patients with HbA1c results and who signed the written consent form

You may not qualify if:

  • \- Patients contraindicated for the approved use of Zemidapa Tab. or have participated in another clinical study within 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

October 26, 2023

Primary Completion

December 3, 2025

Study Completion

December 3, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

KR(1)