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OpenTrials
Completed

NCT Number: NCT06495281

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. change from baseline of HbA1c at 12 weeks

    Time frame: baseline, 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Observational Study to Evaluate Effectiveness, Safety of Triple Combination Therapy of Zemidapa and Metformin in Patients With Type 2 DM Who Received Double or Triple Combination Therapy Including DPP4-inhibitor Other Than Gemigliptin

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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