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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.

A Prospective, Open-Label, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of a Novel Methylcobalamin Nasal Spray (NASO B12) in the Treatment of Vitamin B12 Deficiency in Type II Diabetes Mellitus Patients Receiving Metformin - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088083
Enrollment
20
Registered
2025-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Methylcobalamin nasal spray NASO B12: Each spray will deliver 0.05 ml of a solution containing 250 micro g of methylcobalamin. Treatment Phase 1 puff in each nostril, total two puffs at

Sponsors

Dr Mayur Agrawal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. 2. 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. 4. 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

Exclusion criteria: 1. Pregnant or Lactating Women 2. Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication. 3. Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies, or upper respiratory tract infections. 4. Patient using any other nasal medication/device. 5. Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure. 6. Patients on treatment with drugs that interfere with vitamin B12 assay. 7. Participated in any clinical trial within the last 30 days at the time of screening. 8. Any disorder or condition that in the opinion of the investigator would prohibit study participation or affect the study outcome.

Design outcomes

Primary

MeasureTime frame
To compare the Vitamin B12 level between baseline to various time-pointsTimepoint: 10 months—

Secondary

MeasureTime frame
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. 3. Occurrence of any local or systemic adverse event.Timepoint: 10 months—

Countries

India

Contacts

Public ContactDr Mukul Maurya

Hormone India Diabetes & Endocrine Centre

mayuragrawal2006@gmail.com8989893232

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026