NCT06241638

Brief Summary

The current study was conducted to evaluate the prognostic implications of vitamin B12 admission on BMI and HbA1c levels in type 2 diabetic patients treated with Dapagliflozin as a routine medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

October 2, 2025

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 18, 2024

Last Update Submit

September 29, 2025

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c in the two groups

    The diabetic status in the two groups was evaluated by measuring the HbA1c levels

    One year

Study Arms (2)

Dapagliflozin group

ACTIVE COMPARATOR

Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months

Drug: Dapagliflozin 10mg Tab

Vitamin B12 and Dapagliflozin group

EXPERIMENTAL

Vitamin B12 and Dapagliflozin group received orally Vit. B12 supplements methylcobalamin 500 µg once daily with their usual anti-diabetic therapy Dapagliflozin 10 mg/daily for twelve months.

Drug: Vitamin B12 0.5 MG/ACTUATDrug: Dapagliflozin 10mg Tab

Interventions

Vitamin B12 0.5 MG/ACTUATDRUG

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group. The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Vitamin B12 and Dapagliflozin group
Dapagliflozin 10mg TabDRUG

The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group. The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Dapagliflozin groupVitamin B12 and Dapagliflozin group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patient treated with Dapagliflozin

You may not qualify if:

  • The levels of Vitamin B12 more than 200 ng/ml

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walid Aburayyan

Salt, 961343, Jordan

Location

Related Publications (1)

  • Aburayyan W, Zakaraya Z, Hamad M, Majali IS, Abu Dayyih W, Seder N, Alkhadeir H, Khaleel A. Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers, Combined with Dapagliflozin as Type 2 Diabetes Mellitus Routine Treatment: A Controlled Randomized, Double-blind Trial. Iran J Med Sci. 2025 May 1;50(5):324-333. doi: 10.30476/ijms.2024.101606.3423. eCollection 2025 May.

    PMID: 40433181DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vitamin B 12dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 5, 2024

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 2, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)