NCT06191614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

December 17, 2023

Last Update Submit

February 13, 2024

Conditions

Diabetic Peripheral Neuropathy

Keywords

R-thioctic acid tromethamine

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Study Officials

  • Ho-chan Cho

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 5, 2024

Study Start

May 19, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

KR(1)