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

NCT06400888 | Not Yet Recruiting

• 2 other identifiers: M2024117HP2024-03-501004
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• concentration of plasma vitamin B12

  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

  The corneal nerve fiber length in inferior whorl area.

  baseline, 8 weeks

• corneal confocal microscopy parameter: corneal nerve fiber length

  The corneal nerve fiber length per frame.

  baseline, 8 weeks

Secondary Outcomes (12)

• neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)

  baseline, 8 weeks

• neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN)

  baseline, 8 weeks

• neurological function scales score: Neuropathy Impairment Score (NIS)

  baseline, 8 weeks

• neurological function scales score: Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests)

  baseline, 8 weeks

• neurological function scales score: Polyneuropathy disability (PND) score

  baseline, 8 weeks

Study Arms (2)

needle free subcutaneous injector of mecobalamin

ACTIVE COMPARATOR

Other: needle-free subcutaneous injector for Mecbl

intramuscular injection of Mecbl

ACTIVE COMPARATOR

Other: intramuscular injection of Mecbl

Interventions

needle-free subcutaneous injector for Mecbl OTHER

needle-free subcutaneous injector for Mecbl

needle free subcutaneous injector of mecobalamin

intramuscular injection of Mecbl OTHER

intramuscular injection of Mecbl

intramuscular injection of Mecbl

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age 18-70 years.
• Participants who have been diagnosed with type 1 or type 2 diabetes for at least 1 year.
• Meet the diagnosis of peripheral neuropathy according to neuroelectrophysiological examination.
• 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.
• No history of eye trauma or corneal laser treatment.
• No history of keratopathy or other intraocular ophthalmic disease.
• No history of wearing contact lenses.
• Have not taken medicines that affect corneal metabolism.
• Did not take Mecbl or α-lipoic acid therapy within 3 months before screening.
• 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.
• Signs the informed consent.
• Subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory tests and other study procedures.

You may not qualify if:

• Have been diagnosed with a malignant tumor in the past 2 years.
• The presence of other neurological disorders that researchers believe perhaps affect the evaluation of DPN.
• The presence of skin diseases in the affected skin areas may affect the evaluation of DPN and injection according to the researcher's judgment.
• Amputation of the ends of fingers and toes.
• Participated in any other trials involving a study or post-marketing drug within 30 days of screening.
• 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.
• 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.
• The WBC \< 4000 / mm\^2, neutrophils count \<1500/mm\^2, platelet count \<100×109 /mm\^2.
• Clinically significant abnormalities in 12-lead ECG.
• Subjects received combining transcutaneous electrical nerve stimulation (TENS) or acupuncture.
• A history of intolerance or allergy to Mecbl or similar chemical compound.
• Current or history presence of alcohol and/or other substance abuse within the past 1 year.
• 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.
• Inability and/or unwillingness to understand and/or comply with the plan.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Interventions

Vitamin B 12

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Department of Neurology

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 6, 2024
• Study Start: May 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05