Diabetic Peripheral NeuropathyNCT06191614
DEXINEURO® Tab on Blood Glucose Reduction in Patients With Type 2 Diabetes Accompanied by Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- How many people
- 528 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 May 2022to 30 Jun 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Prescribed DEXINEURO® tab for the treatment of diabetic peripheral neuropathy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- R-thioctic acid tromethamine
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 12 weeks of prescription for DEXINEURO tab compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start19 May 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 528 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ho-chan Cho, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191614
- Sponsor's protocol ID
- HL-DXNR-401
- Status last verified
- Feb 2024
- First submitted
- 17 Dec 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06191614
- Acronym / sponsor ID
- HL-DXNR-401
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- R-thioctic acid tromethamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Prescribed DEXINEURO® tab for the treatment of diabetic peripheral neuropathy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-chan Cho principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting plasma glucose (FPG) after 12 of DEXINEURO® tab administration compared to baseline (time frame: after 12 weeks of prescription for DEXINEURO tab compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.