Diabetic Peripheral NeuropathyNCT06400888
Needle-Free Subcutaneous Injector and Conventional Intramuscular Injection of Mecobalamin in Diabetes Peripheral Neuropathy
A study testing needle-free subcutaneous injector for Mecbl and intramuscular injection of Mecbl in people with Diabetic Peripheral Neuropathy, run by Peking University Third Hospital.
Trial summary
The evaluation for efficacy and safety of needle-free subcutaneous injector and conventional intramuscular injection of mecobalamin for diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- needle-free subcutaneous injector for Mecbl and intramuscular injection of Mecbl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
The evaluation for efficacy and safety of needle-free subcutaneous injector and conventional intramuscular injection of mecobalamin for diabetic neuropathy.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- needle-free subcutaneous injector for Mecbl, intramuscular injection of Mecbl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle-free subcutaneous injector for MecblOther
needle-free subcutaneous injector for Mecbl
intramuscular injection of MecblOther
intramuscular injection of Mecbl
| Study group | Role | What they receive |
|---|---|---|
| needle free subcutaneous injector of mecobalamin | Active comparator | Not described Receives: Other: needle-free subcutaneous injector for Mecbl |
| intramuscular injection of Mecbl | Active comparator | Not described Receives: Other: intramuscular injection of Mecbl |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of plasma vitamin B12
The plasma vitamin B12, biomarker for effective active metabolite for neural repair.
Measured: 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.
Measured: baseline, 8 weeks
corneal confocal microscopy parameter: corneal nerve fiber length
The corneal nerve fiber length per frame.
Measured: baseline, 8 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Nerve conduction latency
Measured: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Nerve conduction velocity
Measured: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Nerve conduction wave amplitude
Measured: baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Velocity of sympathetic skin response
Measured: baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Amplitude of sympathetic skin response
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start30 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjin Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400888
- Sponsor's protocol ID
- M2024117
- Other IDs
- HP2024-03-501004
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06400888
- Acronym / sponsor ID
- M2024117
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evaluation for efficacy and safety of needle-free subcutaneous injector and conventional intramuscular injection of mecobalamin for diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| needle-free subcutaneous injector for Mecblneedle-free subcutaneous injector for Mecbl | Other | needle free subcutaneous injector of mecobalamin |
| intramuscular injection of Mecblintramuscular injection of Mecbl | Other | intramuscular injection of Mecbl |
Primary outcome
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.
corneal confocal microscopy parameter: inferior whorl length
Time frame: baseline, 8 weeks
The corneal nerve fiber length in inferior whorl area.
corneal confocal microscopy parameter: corneal nerve fiber length
Time frame: baseline, 8 weeks
The corneal nerve fiber length per frame.
12 secondary outcomes
neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS)
Time frame: baseline, 8 weeks
neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN)
Time frame: baseline, 8 weeks
neurological function scales score: Neuropathy Impairment Score (NIS)
Time frame: 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
neurological function scales score: Polyneuropathy disability (PND) score
Time frame: baseline, 8 weeks
neurological function scales score: DNS score
Time frame: baseline, 8 weeks
neurological function scales score: NDS score
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: NCV
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Time frame: baseline, 8 weeks
neuroelectrophysiological parameter: SSR
Time frame: baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing needle-free subcutaneous injector for Mecbl and intramuscular injection of Mecbl in people with Diabetic Peripheral Neuropathy, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of plasma vitamin B12 (time frame: baseline, half an hour, first hour, second hour, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.