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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy

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

• Study Type: Observational
• Enrollment (Actual): 528

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients Prescribed DEXINEURO® tab for the treatment of diabetic peripheral neuropathy

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Individuals who have taken or are currently taking alpha-lipoic acid (thioctic acid) within 1 month before screening.
2. Individuals contraindicated according to the approval conditions of DEXINEURO® tab.
3. Pregnant or breastfeeding women.
4. 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).
5. Individuals whom the principal investigator deems inappropriate for participation in this study for reasons other than those mentioned above.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline	Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline	after 12 weeks of prescription for DEXINEURO tab compared to baseline

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: Ho-chan Cho, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: R-thioctic acid tromethamine
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: HL-DXNR-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No