Diabetic NeuropathiesPhase 2NCT04372316
A Randomized Controlled Trial of Mecobalamin Injection and Tablet Treatment Efficacy on Mild to Moderate Diabetic Peripheral Neuropathy
A Phase 2 study testing methylcobalamin in people with Diabetic Neuropathies, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of mecobalamin injection and tablet in the treatment of small fiber lesions in the early stage of diabetic peripheral neuropathy by corneal confocal microscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- methylcobalamin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2017to Dec 2021
- Phase
- Phase 2
- 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
- diagnosis of type 1 or 2 diabetes for at least 1 year
- must be consistent with the diagnosis of distal, symmetrical, sensorimotor polyneuropathy
- according to the clinical judgment of the researchers, the blood glucose has been under the best control. Before screening visit, HbA1c level ≤ 9%. During the course of the study, the blood glucose was adjusted under the guidance of the researchers, and the blood glucose was kept stable as much as possible.
- Toronto clinical neuropathy score (TCSs) ≤ 5 at screening visit
- no history of eye injury and laser treatment
- no history of keratopathy or other intraocular and extraocular diseases
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- no wearing history of corneal contact lens
- no drugs affecting corneal metabolism
- no Mecobalamin or lipoic acid in 3 months
- women of childbearing age (e.g. non-surgical contraception or menopause less than 1 year) must be negative in the gonadotropin pregnancy test (urine) during the screening period, and effective contraceptive measures must be taken during the treatment period and within 1 month after the end of the treatment
- the participant signs the informed consent, indicating that the subject has been informed of all research related contents
- participants are willing and able to follow study visit arrangements, treatment plans, laboratory tests and other research procedures
Who cannot join
- has been diagnosed as a malignant tumor in the past 2 years.
- the presence of other neurological disorders that the researchers believe may affect the evaluation of diabetic peripheral neuropathy
- presence of skin disease in the affected skin area, which, in the judgment of the researchers, may affect the evaluation of diabetic peripheral neuropathy
- amputations other than finger ends and toes
- participated in any other studies or post market drugs studies within 30 days prior to screening
- participants with clinically significant or unstable diseases, such as but not limited to acute cardiovascular disease, cerebrovascular disease, liver, kidney, respiratory system, blood system, immune system, inflammatory or rheumatic disease, uncontrolled infection, symptomatic peripheral vascular disease, untreated endocrine disease, etc
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- have donated blood within 30 days prior to the start of the study treatment (if applicable); or have prepared blood donors during the study or within 30 days after the end of the treatment
- WBC < 4000 / mm3; neutrophil count < 1500 / mm3; platelet count < 100 × 103 / mm3
- clinically significant abnormal 12 lead ECG
- participants received combined transcutaneous electrical nerve stimulation (TENS) or acupuncture
- previous history of intolerance or allergies to study drugs or drugs with similar chemical structure
- has a history of alcohol and / or other drug abuse in the past year or is currently under the influence of alcohol or drug abuse
- the presence of other acute or chronic medical or psychiatric conditions or laboratory abnormalities that, in the judgment of the investigator, may increase the risk associated with participating in the trial or using the study product, or may affect the interpretation of the study results, may make the subject unsuitable for the trial
- inability and / or unwillingness to understand and / or comply with the program
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Dongsheng Fan
About this study
Official title: The Efficacy of Mecobalamin Injection and Tablet Treatment on Mild to Moderate Diabetic Peripheral Neuropathy： a Randomized Controlled Clinical Trial
To evaluate the efficacy of mecobalamin injection and tablet in the treatment of small fiber lesions in the early stage of diabetic peripheral neuropathy by corneal confocal microscopy.
- Conditions
- Diabetic Neuropathies
- Being tested
- methylcobalamin
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylcobalaminDrug
methylcobamin injection 8 weeks or tablet 8 weeks， followed by 24 weeks methylcobamin tablet until 32 weeks
| Study group | Role | What they receive |
|---|---|---|
| methylcobalamin injection | Active comparator | Not described Receives: Drug: methylcobalamin |
| methylcobalamin tablet | Active comparator | Not described Receives: Drug: methylcobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of inferior whorl length （IWL）from baseline at 8 weeks
changes of the nerve length of inferior whorl area of each mm2
Measured: 8 weeks
Secondary outcomes (4)
changes of corneal nerve fiber length（CNFL）from baseline at 8 weeks
changes of corneal nerve fiber length sum of each mm2
Measured: 8 weeks
changes of corneal nerve branch density（CNBD）from baseline at 8 weeks
changes of corneal nerve branch density of each mm2
Measured: 8 weeks
changes of corneal nerve fibre density（CNFD）from baseline at 8 weeks
changes of corneal nerve fibre density of each mm2
Measured: 8 weeks
changes of corneal nerve fibre tortuosity （CNFT) from baseline at 8 weeks
changes of corneal nerve fibre tortuosity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start25 Dec 2017
- Primary completionJul 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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, Fan Dongsheng, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372316
- Sponsor's protocol ID
- PUTH2017286
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Fan D, Zhang Y, Zhang S, Wang H, Liu Z, Wang H. Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT. Sci Rep. 2021 Jul 19;11(1):14697. doi: 10.1038/s41598-021-94284-4.
PubMed 34282267
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mecobalamin Injection and Tablet Treatment on Mild to Moderate Diabetic Peripheral Neuropathy： a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04372316
- Acronym / sponsor ID
- PUTH2017286
- Conditions
- Diabetic Neuropathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Dec 2017 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 May 2020 (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.
To evaluate the efficacy of mecobalamin injection and tablet in the treatment of small fiber lesions in the early stage of diabetic peripheral neuropathy by corneal confocal microscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylcobalamin injection | Active comparator | Drug: methylcobalamin |
| methylcobalamin tablet | Active comparator | Drug: methylcobalamin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- diagnosis of type 1 or 2 diabetes for at least 1 year
- must be consistent with the diagnosis of distal, symmetrical, sensorimotor polyneuropathy
- according to the clinical judgment of the researchers, the blood glucose has been under the best control. Before screening visit, HbA1c level ≤ 9%. During the course of the study, the blood glucose was adjusted under the guidance of the researchers, and the blood glucose was kept stable as much as possible.
- Toronto clinical neuropathy score (TCSs) ≤ 5 at screening visit
- no history of eye injury and laser treatment
Key exclusion criteria (14 listed)
- has been diagnosed as a malignant tumor in the past 2 years.
- the presence of other neurological disorders that the researchers believe may affect the evaluation of diabetic peripheral neuropathy
- presence of skin disease in the affected skin area, which, in the judgment of the researchers, may affect the evaluation of diabetic peripheral neuropathy
- amputations other than finger ends and toes
- participated in any other studies or post market drugs studies within 30 days prior to 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 |
|---|---|---|
| methylcobalaminmethylcobamin injection 8 weeks or tablet 8 weeks， followed by 24 weeks methylcobamin tablet until 32 weeks | Drug | methylcobalamin injection, methylcobalamin tablet |
Primary outcome
changes of inferior whorl length （IWL）from baseline at 8 weeks
Time frame: 8 weeks
changes of the nerve length of inferior whorl area of each mm2
4 secondary outcomes
changes of corneal nerve fiber length（CNFL）from baseline at 8 weeks
Time frame: 8 weeks
changes of corneal nerve branch density（CNBD）from baseline at 8 weeks
Time frame: 8 weeks
changes of corneal nerve fibre density（CNFD）from baseline at 8 weeks
Time frame: 8 weeks
changes of corneal nerve fibre tortuosity （CNFT) from baseline at 8 weeks
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Derived from this study: PubMed 34282267Zhang Y, Fan D, Zhang Y, Zhang S, Wang H, Liu Z, Wang H. Using corneal confocal microscopy to compare Mecobalamin intramuscular injections vs oral tablets in treating diabetic peripheral neuropathy: a RCT. Sci Rep. 2021 Jul 19;11(1):14697. doi: 10.1038/s41598-021-94284-4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylcobalamin in people with Diabetic Neuropathies, run by Peking University Third Hospital at 1 site in China.
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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dongsheng Fan (+86 010 82265694, dsfan2010@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of inferior whorl length （IWL）from baseline at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372316, which also lists 1 linked publication.
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 4 May 2020.