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

Completed

• Conditions: Diabetic Peripheral Neuropathy

• Registration Number: NCT06191614
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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 2 diabetes accompanied by 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 Timeline

• Study Start: 2022-05-19
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of