Observational Study of Triple Combination Therapy of Zemidapa Tab. and Metformin in Type 2 Diabetes Mellitus Patients

Recruiting

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT06495281
• Lead Sponsor: LG Chem

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-26
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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:

  1. Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin)
  2. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor)
  3. 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change from baseline of HbA1c at 12 weeks	baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
the rate of subjects who reached the target value of less than 7% HbA1c	12 weeks

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Jeollanam-do, Korea, Republic of