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

Launched by LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES · May 20, 2025

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ClinConnect Summary

This clinical trial is studying the effects of a special form of Vitamin B12, called Sucrosomial® Vitamin B12, on people with Type 2 Diabetes who are also taking a medication called Metformin. Many patients with Type 2 Diabetes can develop a deficiency in Vitamin B12, which is important for many body functions. The trial will compare the effects of taking this Vitamin B12 supplement daily for four weeks against a placebo (a pill that looks like the supplement but has no active ingredients) to see if it helps improve Vitamin B12 levels and other health markers.

To participate, individuals must be between 18 and 75 years old, have been diagnosed with Type 2 Diabetes, and have been on Metformin for at least a year. They also need to have low levels of Vitamin B12 in their blood. However, people who have taken other Vitamin B12 supplements recently or have certain medical conditions may not be eligible. Participants will receive either the Vitamin B12 supplement or the placebo and will be monitored for safety and how well their blood sugar levels are managed during the study. This trial is not yet recruiting, but it aims to find out if this new form of Vitamin B12 can be helpful for those in need.

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Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Able to comply with study procedures and visit schedule.
• Exclusion Criteria:
• • 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.
• • Use of medications known to interfere with vitamin B12 absorption (other than Metformin).
• • Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or end-stage renal disease.
• • Severe hepatic impairment (ALT/AST \> 3 times the upper limit of normal).
• • Pregnant or breastfeeding women.
• • Known hypersensitivity to vitamin B12 or any component of the study product.
• • Participation in another clinical trial within the last 30 days.