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

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: Not yet recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: needle-free subcutaneous injector for Mecbl; Other: intramuscular injection of Mecbl

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)	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)	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)	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)	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	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	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	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	Nerve conduction latency	baseline, 8 weeks
neuroelectrophysiological parameter: NCV	Nerve conduction velocity	baseline, 8 weeks
neuroelectrophysiological parameter: NCV	Nerve conduction wave amplitude	baseline, 8 weeks
neuroelectrophysiological parameter: SSR	Velocity of sympathetic skin response	baseline, 8 weeks
neuroelectrophysiological parameter: SSR	Amplitude of sympathetic skin response	baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID 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