A Randomized Controlled Trial of Mecobalamin Injection and Tablet Treatment Efficacy on Mild to Moderate Diabetic Peripheral Neuropathy

What Was Tested

In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had two arms (groups): methylcobalamin injection (active comparator) and methylcobalamin tablet (active comparator).

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of type 1 or 2 diabetes for at least 1 year. Must be consistent with the diagnosis of distal, symmetrical, sensorimotor polyneuropathy. 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.

The full record lists 12 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-12-25 with completion listed for 2020-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example changes of corneal nerve fiber length（CNFL）from baseline at 8 weeks, changes of corneal nerve branch density（CNBD）from baseline at 8 weeks, changes of corneal nerve fibre density（CNFD）from baseline at 8 weeks and changes of corneal nerve fibre tortuosity （CNFT) from baseline at 8 weeks.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.