Clinical trial NCT06400888: Needle-Free Subcutaneous Injector and Conventional Intramuscular Injection of Mecobalamin in Diabetes Peripheral Neuropathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: concentration of plasma vitamin B12
timeFrame: baseline, half an hour, first hour, second hour, 8 weeks
measure: corneal confocal microscopy parameter: inferior whorl length
timeFrame: baseline, 8 weeks
measure: corneal confocal microscopy parameter: corneal nerve fiber length
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)
timeFrame: baseline, 8 weeks
measure: neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN)
timeFrame: baseline, 8 weeks
measure: neurological function scales score: Neuropathy Impairment Score (NIS)
timeFrame: baseline, 8 weeks
measure: neurological function scales score: Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests)
timeFrame: baseline, 8 weeks
measure: neurological function scales score: Polyneuropathy disability (PND) score
timeFrame: baseline, 8 weeks
measure: neurological function scales score: DNS score
timeFrame: baseline, 8 weeks
measure: neurological function scales score: NDS score
timeFrame: baseline, 8 weeks
measure: neuroelectrophysiological parameter: NCV
timeFrame: baseline, 8 weeks
measure: neuroelectrophysiological parameter: NCV
timeFrame: baseline, 8 weeks
measure: neuroelectrophysiological parameter: NCV
timeFrame: baseline, 8 weeks
measure: neuroelectrophysiological parameter: SSR
timeFrame: baseline, 8 weeks
measure: neuroelectrophysiological parameter: SSR
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
Study officials:
References: