A study to test how safe and effective a new vitamin B12 nasal spray (called NASO B12) is for treating vitamin B12 deficiency in people with type 2 diabetes who are taking the medicine metformin.

Recruiting

• Conditions: Type 2 diabetes mellitus with other specified complications,

• Registration Number: CTRI/2025/06/088083
• Lead Sponsor: Dr Mayur Agrawal

Brief Summary

Vitamin B12, also known as cobalamin, anti-pernicious anaemia factor, Castle’s extrinsic factor, or animal protein factor is the largest and most complex of all the vitamins. It is necessary for the formation of blood cells, nerve sheaths, and various proteins. It is also involved in fat and carbohydrate metabolism. It is also essential for DNA synthesis, cellular energy production, and growth. Vitamin B12 is also required in the synthesis of folate polyglutamates (active coenzymes required in the formation of nerve tissue) and in the regeneration of folic acid during red blood cell formation. Cobalamin Deficiency is defined as

B12 levels less than 200pg/mL and SCCD or Subclinical Cobalamin Deficiency refers to B12 levels less than 400pg/mL. Evidence indicates methylcobalamin is utilized more efficiently than cyanocobalamin to

increase levels of one of the coenzyme forms of vitamin B12. Experiments have shown similar absorption of methylcobalamin & cyanocobalamin following oral administration. Also, the quantity of cobalamin detected following a small oral dose of methylcobalamin is similar to the amount following administration of cyanocobalamin; but significantly more cobalamin accumulates in liver tissue following administration of methylcobalamin. Human urinary excretion of methylcobalamin is about one-third that of a similar dose of cyanocobalamin, indicating substantially greater tissue retention. Thus, methylcobalamin has greater utility over cyanocobalamin. Nasal Methylcobalamin therapy has been introduced as an innovative route for the systemic availability of B12 due to the large surface area, porous endothelial membrane, high total blood flow, the avoidance of first-pass metabolism, and ready accessibility of the route. Methylcobalamin is absorbed rapidly, safely, and consistently from the nasal cavity after intranasal administration. Further, the intranasal formulation has overcome the drawbacks of the intramuscular formulation. It is convenient and painless. Nasal Methylcobalamin Spray can eliminate the need for the assistance of Nursing staff or Paramedics for injection and reduce the overall cost of therapy. It would also facilitate ease of administration and improve compliance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-29
• Study Start: 2025-09-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Type II Diabetic Mellitus patients who are on Metformin (more than and equal to 1000mg/day) therapy since more than or equal to 4 months.
• Vitamin B12 level more than 200 pg/mL (148 pmol/L) 3.
• Willing & able to comply with study requirements, e.g. usage of medicines as per protocol, willing to adhere to study visit schedule, and willing to fill Patient Diary, as indicated by written informed consent provided by the patient.
• If women of childbearing potential are recruited they must be non-pregnant (supported by a negative urine pregnancy test at screening), and be willing to maintain reliable birth control throughout the study.

Exclusion Criteria

• Pregnant or Lactating Women 2.
• Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
• Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies, or upper respiratory tract infections.
• Patient using any other nasal medication/device.
• Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure.
• Patients on treatment with drugs that interfere with vitamin B12 assay.
• Participated in any clinical trial within the last 30 days at the time of screening.
• Any disorder or condition that in the opinion of the investigator would prohibit study participation or affect the study outcome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the Vitamin B12 level between baseline to various time-points	10 months

Secondary Outcome Measures

Name	Time	Method
1. To record the duration of time the serum Vitamin B12 level remained more than and equal to 400 pg/mL after last dose	2. To record the duration of time the serum Vitamin B12 level remained more than or equal to 200 pg/mL after last dose.

Trial Locations

Locations (1)

Hormone India Diabetes & Endocrine Centre; 🇮🇳 Bhopal, MADHYA PRADESH, India

Hormone India Diabetes & Endocrine Centre

🇮🇳Bhopal, MADHYA PRADESH, India

Dr Mayur Agrawal

Principal investigator

8989893232

mayuragrawal2006@gmail.com