Status:

COMPLETED

DEXINEURO® Tab on Blood Glucose Reduction in Patients With Type 2 Diabetes Accompanied by Diabetic Peripheral Neuropathy

Lead Sponsor:

Hanlim Pharm. Co., Ltd.

Conditions:

Diabetic Peripheral Neuropathy

Eligibility:

All Genders

19+ years

Brief Summary

This study is to evaluate the efficacy of DEXINEURO® tab on blood glucose reduction and assess the interaction with concomitantly administered insulin or oral antidiabetic agents in patients with type...

Detailed Description

This clinical trial is a multi-center, single-group, prospective observational study conducted to investigate the interaction with concomitant insulin or oral antidiabetic agents and assess the influe...

Eligibility Criteria

Inclusion

  • Adults aged 19 years and older of both genders.
  • Type 2 diabetes patients with HbA1c ≤ 10% at screening.
  • Patients diagnosed with diabetic peripheral neuropathy who are scheduled to receive DEXINEURO® tab.
  • Individuals who have voluntarily provided written consent to participate in this study.

Exclusion

  • Individuals who have taken or are currently taking alpha-lipoic acid (thioctic acid) within 1 month before screening.
  • Individuals contraindicated according to the approval conditions of DEXINEURO® tab.
  • Pregnant or breastfeeding women.
  • Individuals participating in other clinical trials (except for non-interventional observational studies, if they have not received investigational drugs, or are participating in other non-interventional observational studies).
  • Individuals whom the principal investigator deems inappropriate for participation in this study for reasons other than those mentioned above.

Key Trial Info

Start Date :

May 19 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2023

Estimated Enrollment :

528 Patients enrolled

Trial Details

Trial ID

NCT06191614

Start Date

May 19 2022

End Date

June 30 2023

Last Update

February 15 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Keimyung University Dongsan Hospital

Daegu, South Korea