Diabetes MellitusNCT06241638
Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers
A study testing Vitamin B12 0.5 MG/ACTUAT and Dapagliflozin 10mg Tab in people with Diabetes Mellitus, run by Al-Balqa Applied University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Vitamin B12 0.5 MG/ACTUAT and Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jul 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patient treated with Dapagliflozin
Who cannot join
- The levels of Vitamin B12 more than 200 ng/ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers, Combined With Dapagliflozin as Type Two Diabetes Mellitus Routine Treatment
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.
Read the detailed description
Eighty diabetic patients were enrolled in this study; 37 females and 43 males with inclusion criteria of vitamin B12 levels less than 233 ng/ml. The participants were divided into two groups, the Dapagliflozin group (active comparator group) received only the diabetic-controlling drug Dapagliflozin 10 mg/daily orally for twelve months, whereas, vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for twelve months. Glycemic control was measured by monitoring levels of HbA1c and Vitamin B12 in the participant's blood four times at time intervals of three months during the study period. Additionally, the weight measurements were recorded during the study period at time intervals of three months and BMI was calculated. The data obtained was treated by statistical analysis using SPSS software (version 20) for the significant correlation of the independent variables of the study groups after vitamin B12 supplementation.
- Conditions
- Diabetes Mellitus
- Being tested
- Vitamin B12 0.5 MG/ACTUAT, Dapagliflozin 10mg Tab
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Active comparator | Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months Receives: 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. Receives: Drug: Vitamin B12 0.5 MG/ACTUAT; Drug: Dapagliflozin 10mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c in the two groups
The diabetic status in the two groups was evaluated by measuring the HbA1c levels
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Balqa Applied University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Salem Aburayyan, Al-Balqa Applied University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241638
- Sponsor's protocol ID
- SREC-2022/783
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40433181
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers, Combined With Dapagliflozin as Type Two Diabetes Mellitus Routine Treatment
- ClinicalTrials.gov ID
- NCT06241638
- Acronym / sponsor ID
- SREC-2022/783
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Balqa Applied UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eighty diabetic patients were enrolled in this study; 37 females and 43 males with inclusion criteria of vitamin B12 levels less than 233 ng/ml. The participants were divided into two groups, the Dapagliflozin group (active comparator group) received only the diabetic-controlling drug Dapagliflozin 10 mg/daily orally for twelve months, whereas, vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for twelve months. Glycemic control was measured by monitoring levels of HbA1c and Vitamin B12 in the participant's blood four times at time intervals of three months during the study period. Additionally, the weight measurements were recorded during the study period at time intervals of three months and BMI was calculated. The data obtained was treated by statistical analysis using SPSS software (version 20) for the significant correlation of the independent variables of the study groups after vitamin B12 supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Active comparator | Drug: Dapagliflozin 10mg TabDapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months |
| Vitamin B12 and Dapagliflozin group | Experimental | Drug: Vitamin B12 0.5 MG/ACTUAT, Drug: Dapagliflozin 10mg TabVitamin 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patient treated with Dapagliflozin
Key exclusion criteria (1 listed)
- The levels of Vitamin B12 more than 200 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B12 0.5 MG/ACTUATThe 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. | Drug | Vitamin B12 and Dapagliflozin group |
| Dapagliflozin 10mg TabThe 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. | Drug | Dapagliflozin group, Vitamin B12 and Dapagliflozin group |
Primary outcome
HbA1c in the two groups
Time frame: One year
The diabetic status in the two groups was evaluated by measuring the HbA1c levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 40433181Aburayyan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 0.5 MG/ACTUAT and Dapagliflozin 10mg Tab in people with Diabetes Mellitus, run by Al-Balqa Applied University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c in the two groups (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.