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

Diabetic Peripheral Neuropathy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06191614
• Other study ID #: HL-DXNR-401
• Status: Completed
• Start date: May 19, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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