Oral Sucrosomial® Vitamin B12 in the Management of B12 Deficiency Among Metformin-Treated Type 2 Diabetes Patients

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

Secondary outcomes include assessment of safety, tolerability, and glycemic control (HbA1c).

It had two arms (groups): Sucrosomial® B12 Group (experimental) and Placebo Group (placebo comparator).

The registry classes the interventions as dietary supplement and other.

More on the Plan

Vitamin B12 deficiency is a common concern in Type 2 Diabetes Mellitus (T2DM) patients, especially those treated with metformin, which is known to interfere with B12 absorption.

The study will enroll 50 participants (25 in each group) who will receive either Sucrosomial® B12 or placebo for 4 weeks.

Primary Outcome: Change in serum vitamin B12 levels from baseline to 3 weeks.

Secondary Outcomes: Change in Holo-Transcobalamin II (HoloTCII) levels from baseline to 3 weeks.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adults aged 18 to 75 years. Diagnosed with Type 2 Diabetes Mellitus (T2DM). Currently on Metformin therapy for at least one year. Serum vitamin B12 levels below the laboratory reference range (indicating deficiency). Willing to provide written informed consent.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: current or prior use of vitamin b12 supplements within the past 3 months; diagnosis of pernicious anemia or other causes of vitamin b12 malabsorption (e.g., crohn's disease, celiac disease); history of gastric surgery or small intestine resection.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-08-15 with completion listed for 2025-12-03.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Serum Vitamin B12 Levels (time frame: Baseline, 24 hours, 7 days, 14 days, and 21 days).

It also tracked 5 secondary outcomes, for example Change in Holo-Transcobalamin II (HoloTCII) Levels, Change in Transcobalamin I (TCI) Levels, Change in Gastric intrinsic factor levels, Change in Holotranscobalamin (active B12) Levels and Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Sucrosomial® B12).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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