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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06191614

Enrollment

528

Registered

2024-01-05

Start date

2022-05-19

Completion date

2023-06-30

Last updated

2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Keywords

R-thioctic acid tromethamine

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results