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NCT Number: NCT06191614

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

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 2 diabetes accompanied by diabetic peripheral neuropathy.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keimyung University Dongsan Hospital

Daegu, South Korea

About this study

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 influence on blood glucose reduction when administering DEXINEURO® tab to patients with type 2 diabetes and diabetic peripheral neuropathy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline

    Time frame: after 12 weeks of prescription for DEXINEURO tab compared to baseline

    Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

Multi-center, Single-group, Prospective Observational Study to Evaluate the Efficacy of DEXINEURO Tab on Blood Glucose Reduction in Type 2 Diabetic Patients With Diabetic Peripheral Neuropathy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Feb 15, 2024

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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