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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Other: needle-free subcutaneous injector for Mecbl; Other: intramuscular injection of Mecbl

• Registration Number: NCT06400888
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Study Start: 2024-05-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
needle free subcutaneous injector of mecobalamin	needle-free subcutaneous injector for Mecbl	-
intramuscular injection of Mecbl	intramuscular injection of Mecbl	-

Primary Outcome Measures

Name	Time	Method
corneal confocal microscopy parameter: corneal nerve fiber length	baseline, 8 weeks	The corneal nerve fiber length per frame.
concentration of plasma vitamin B12	baseline, half an hour, first hour, second hour, 8 weeks	The plasma vitamin B12, biomarker for effective active metabolite for neural repair.
corneal confocal microscopy parameter: inferior whorl length	baseline, 8 weeks	The corneal nerve fiber length in inferior whorl area.

Secondary Outcome Measures

Name	Time	Method
neurological function scales score: NDS score	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.
neurological function scales score: Polyneuropathy disability (PND) score	baseline, 8 weeks	Polyneuropathy disability grades of walking. 0-IV grades were measured. More score is more severe impairment.
neurological function scales score: DNS score	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.
neuroelectrophysiological parameter: SSR	baseline, 8 weeks	Amplitude of sympathetic skin response
neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)	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.
neurological function scales score: Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests)	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.
neuroelectrophysiological parameter: NCV	baseline, 8 weeks	Nerve conduction wave amplitude
neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN)	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.
neurological function scales score: Neuropathy Impairment Score (NIS)	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.