Needle-Free Subcutaneous Injector and Conventional Intramuscular Injection of Mecobalamin in Diabetes Peripheral Neuropathy

May 1, 2024 updated by: Yuanjin Zhang, Peking University Third Hospital

a Prospective, Randomized, Open-Label, Clinical Trial Study Comparing the Efficacy and Safety for Needle-Free Subcutaneous Injector and Conventional Intramuscular Injection of Mecobalamin in Diabetes Peripheral Neuropathy

The evaluation for efficacy and safety of needle-free subcutaneous injector and conventional intramuscular injection of mecobalamin for diabetic neuropathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects, age 18-70 years.
  2. Participants who have been diagnosed with type 1 or type 2 diabetes for at least 1 year.
  3. Meet the diagnosis of peripheral neuropathy according to neuroelectrophysiological examination.
  4. According to the researchers' clinical judgment, blood glucose has been optimally controlled. The blood glucose was kept as stable as possible during the study. HbA1c level≤9% prior to screening, the variety is at least less than 2% within the 3-months before enrollment.
  5. No history of eye trauma or corneal laser treatment.
  6. No history of keratopathy or other intraocular ophthalmic disease.
  7. No history of wearing contact lenses.
  8. Have not taken medicines that affect corneal metabolism.
  9. Did not take Mecbl or α-lipoic acid therapy within 3 months before screening.
  10. Women of child bearing age (e.g., non-operative birth control or pausimenia less than 1 year) must be negative in the gonadotropin pregnancy test (urine) screening and receive effective contraception during treatment.
  11. Signs the informed consent.
  12. Subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  1. Have been diagnosed with a malignant tumor in the past 2 years.
  2. The presence of other neurological disorders that researchers believe perhaps affect the evaluation of DPN.
  3. The presence of skin diseases in the affected skin areas may affect the evaluation of DPN and injection according to the researcher's judgment.
  4. Amputation of the ends of fingers and toes.
  5. Participated in any other trials involving a study or post-marketing drug within 30 days of screening.
  6. Subjects with clinically significant or unstable diseases, such as but not limited to acute cardiovascular diseases, cerebrovascular diseases, liver diseases, kidney diseases, respiratory diseases, blood diseases, immune system diseases, inflammatory or rheumatic diseases, uncontrolled infections, symptomatic peripheral vascular diseases, untreated endocrine diseases, etc.
  7. Had donated blood within 30 days of the study treatment commencement (if applicable); or preparative blood donors during the study or 30 days after the end of treatment.
  8. The WBC < 4000 / mm^2, neutrophils count <1500/mm^2, platelet count <100×109 /mm^2.
  9. Clinically significant abnormalities in 12-lead ECG.
  10. Subjects received combining transcutaneous electrical nerve stimulation (TENS) or acupuncture.
  11. A history of intolerance or allergy to Mecbl or similar chemical compound.
  12. Current or history presence of alcohol and/or other substance abuse within the past 1 year.
  13. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that, in the determination of the investigator, may increase the risk associated with participating in the trial or using Mecbl, or that may affect the interpretation of the study results, may render the subject unfit to participate in the trial.
  14. Inability and/or unwillingness to understand and/or comply with the plan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: needle free subcutaneous injector of mecobalamin
Other: needle-free subcutaneous injector for Mecbl
needle-free subcutaneous injector for Mecbl
Active Comparator: intramuscular injection of Mecbl
Other: intramuscular injection of Mecbl
intramuscular injection of Mecbl

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
concentration of plasma vitamin B12
Time Frame: baseline, half an hour, first hour, second hour, 8 weeks
The plasma vitamin B12, biomarker for effective active metabolite for neural repair.
baseline, half an hour, first hour, second hour, 8 weeks
corneal confocal microscopy parameter: inferior whorl length
Time Frame: baseline, 8 weeks
The corneal nerve fiber length in inferior whorl area.
baseline, 8 weeks
corneal confocal microscopy parameter: corneal nerve fiber length
Time Frame: baseline, 8 weeks
The corneal nerve fiber length per frame.
baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)
Time Frame: baseline, 8 weeks
mTCNS is a valid and reliable scale for staging of mild to moderate diabetic sensorimotor polyneuropathy. Value of 3 or more is recommended for the diagnosis of peripheral neuropathy.
baseline, 8 weeks
neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN)
Time Frame: baseline, 8 weeks
A patient-reported outcomes measure reflecting small fiber, physical functioning/large fiber neuropathy, autonomic nerve function, symptoms, and activities of daily living. Ranges from -4 to 136, higher score indicates worse QOL.
baseline, 8 weeks
neurological function scales score: Neuropathy Impairment Score (NIS)
Time Frame: baseline, 8 weeks
Clinician assessments about cranial nerves and limbs for muscle weakness, sensation loss, and decreased reflexes. ranges from 0 to 244. Higher NIS reflect greater neuropathic impairment.
baseline, 8 weeks
neurological function scales score: Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests)
Time Frame: baseline, 8 weeks
Neuropathy impairment score of the lower limbs plus seven tests includes muscle weakness, sensation loss, and decreased reflexes. Ranges from 0 to 88. More NIS-LL scores indicate greater neuropathic impairment.
baseline, 8 weeks
neurological function scales score: Polyneuropathy disability (PND) score
Time Frame: baseline, 8 weeks
Polyneuropathy disability grades of walking. 0-IV grades were measured. More score is more severe impairment.
baseline, 8 weeks
neurological function scales score: DNS score
Time Frame: baseline, 8 weeks
Score items are unsteadiness of gait, burning or aching sensation, pricking sensation and numbness. A score of one or more denotes the presence of neuropathy.
baseline, 8 weeks
neurological function scales score: NDS score
Time Frame: baseline, 8 weeks
Evaluation of pinprick sensation, vibration sensation and temperature sensation. A total of 10 points was adopted. A score of 6 - 8 denotes the presence of moderate DPN, and a score of 9 - 10 denotes severe DPN.
baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Time Frame: baseline, 8 weeks
Nerve conduction latency
baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Time Frame: baseline, 8 weeks
Nerve conduction velocity
baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Time Frame: baseline, 8 weeks
Nerve conduction wave amplitude
baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Time Frame: baseline, 8 weeks
Velocity of sympathetic skin response
baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Time Frame: baseline, 8 weeks
Amplitude of sympathetic skin response
baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2024117
  • HP2024-03-501004 (Other Grant/Funding Number: 2024 Haidian District Health and Wellness Development Research Incubation Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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