DiabetesPhase 4DMVascularNCT05440591
Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes
A Phase 4 study testing Dapagliflozin, MetFORMIN 500 Mg Oral Tablet and Dapagliflozin / metFORMIN Pill in people with Diabetes, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Dapagliflozin, MetFORMIN 500 Mg Oral Tablet and Dapagliflozin / metFORMIN Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2019to 10 May 2023
- Phase
- Phase 4
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give informed consent
- Age 30-65 years
- Newly diagnosed (within the past 1 - 2 years) to have T2DM and not started on diabetes medications, HbA1c 6.4% to 10% (both inclusive) and/or OGTT 0 min glucose ≥7.0mmol/L and/or 120 min glucose ≥11.8mmol/L OR Recently diagnosed to have T2DM and treated with Metformin for not more than 5 years, HbA1c ≤ 8%
- No recent change in medications or new medications
- eGFR>60mL/min/1.73m2
- Patient is otherwise well with no acute systemic illness in the last 2 weeks.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial
Who cannot join
- History of ketoacidosis or any other conditions causing acidosis e.g. Alcohol dependence
- Has a history of urinary tract infections or is at risk for urinary tract infections (e.g prostatomegaly, vesicoureteric reflux, kidney stones)
- Patients on corticosteroids or immunosuppressive agents
- Patients known to have HIV infection and/or on anti-retroviral agents
- Patients with typical clinical features suggestive of T1DM (young onset with no family history of diabetes or first presentation as DKA were excluded). The endocrinologist (PI or co-I) will look at the patient profile to confirm diagnosis of T2DM.
- Has severe liver dysfunction
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- Considered inappropriate by investigators due to any other reason.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Significant renal impairment.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- Participants who have a history of Peripheral Arterial Disease or peripheral vascular disease or complains of lower limb claudication pain.
- -
Trial locations and contacts
1 site in 1 country.
Siti Zaidah contact
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Siti Zaidah, siti_zaidah_abu_bakar@ttsh.com.sg
Rnkoo Dalan, MBBS
About this study
Official title: Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes- A Randomised Controlled Trial (DMVascular Study)
Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.
Read the detailed description
Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.
Trial Participants: Approximately 150 newly diagnosed T2DM patients with randomization 1:1:1 to Metformin XR 500mg twice daily, Dapagliflozin 10 mg daily or Metformin XR 500/Dapagliflozin 5 mg daily
Primary Aim : To evaluate the influence of intervention on vascular function.
Secondary Aims:
- To evaluate the influence on other parameters of vascular function and beds.
- To evaluate the haemodynamics involving blood pressure regulation.
- To evaluate the effects of SGLT2i versus Metformin on endothelial interactions (vascular permeability) and leukocyte-endothelial interactions (leukocyte rolling, adherence), endothelial regenerative capacity and other endothelial related pathways.
- Conditions
- Diabetes
- Being tested
- Dapagliflozin, MetFORMIN 500 Mg Oral Tablet, Dapagliflozin / metFORMIN Pill
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin 10mg tablets
MetFORMIN 500 Mg Oral TabletDrug
Metformin 500 mg tablets twice daily
Dapagliflozin / metFORMIN PillDrug
Combination pill
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin XR 500 mg tablets - up-to twice daily orally. Receives: Drug: MetFORMIN 500 Mg Oral Tablet |
| Dapagliflozin | Experimental | Dapagliflozin 10 mg tablets - once daily Receives: Drug: Dapagliflozin |
| MetforminXR 500/Dapagliflozin 5mg | Experimental | MetforminXR 500/Dapagliflozin 5mg , tablets- once daily Receives: Drug: Dapagliflozin / metFORMIN Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)
Measured: 3 months after initiation
Carotid Femoral Pulse Wave Velocity
Sphygmocor determined cf-PWV
Measured: 3 months after initiation
Secondary outcomes (3)
Augmentation index
Augmentation index-sphygmocor derived and RHI-endoPAT derived
Measured: 3 months after initiation
Central pulse pressure
CPP-Sphygmocor derived
Measured: 3 months after initiation
Advanced glycation end products
AGE reader measurements
Measured: 3 months after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Apr 2019
- Primary completion10 May 2023 (estimated)
- Study completion10 May 2023 (estimated)
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 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label Parallel Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rinkoo Dalan, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440591
- Sponsor's protocol ID
- DMV001
- Acronym
- DMVascular
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chee YJ, Acharyya S, Liew H, Seow CJ, Goh LL, Boehm BO, Dalan R. First-Line Dapagliflozin, Metformin, or Combination Therapy in Type 2 Diabetes: Vascular and Molecular Outcomes of a Randomised Controlled Trial. Diabetes Obes Metab. 2026 Jul 3. doi: 10.1111/dom.71056. Online ahead of print.
PubMed 42396722
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes- A Randomised Controlled Trial (DMVascular Study)
- ClinicalTrials.gov ID
- NCT05440591
- Acronym / sponsor ID
- DMVascular / DMV001
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 10 May 2023 (estimated)
- First posted
- 1 Jul 2022 (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.
Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.
Detailed description
Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.
Trial Participants: Approximately 150 newly diagnosed T2DM patients with randomization 1:1:1 to Metformin XR 500mg twice daily, Dapagliflozin 10 mg daily or Metformin XR 500/Dapagliflozin 5 mg daily
Primary Aim : To evaluate the influence of intervention on vascular function.
Secondary Aims:
- To evaluate the influence on other parameters of vascular function and beds.
- To evaluate the haemodynamics involving blood pressure regulation.
- To evaluate the effects of SGLT2i versus Metformin on endothelial interactions (vascular permeability) and leukocyte-endothelial interactions (leukocyte rolling, adherence), endothelial regenerative capacity and other endothelial related pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open Label Parallel Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetFORMIN 500 Mg Oral TabletMetformin XR 500 mg tablets - up-to twice daily orally. |
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin 10 mg tablets - once daily |
| MetforminXR 500/Dapagliflozin 5mg | Experimental | Drug: Dapagliflozin / metFORMIN PillMetforminXR 500/Dapagliflozin 5mg , tablets- once daily |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to give informed consent
- Age 30-65 years
- Newly diagnosed (within the past 1 - 2 years) to have T2DM and not started on diabetes medications, HbA1c 6.4% to 10% (both inclusive) and/or OGTT 0 min glucose ≥7.0mmol/L and/or 120 min glucose ≥11.8mmol/L OR Recently diagnosed to have T2DM and treated with Metformin for not more than 5 years, HbA1c ≤ 8%
- No recent change in medications or new medications
- eGFR>60mL/min/1.73m2
Key exclusion criteria (13 listed)
- History of ketoacidosis or any other conditions causing acidosis e.g. Alcohol dependence
- Has a history of urinary tract infections or is at risk for urinary tract infections (e.g prostatomegaly, vesicoureteric reflux, kidney stones)
- Patients on corticosteroids or immunosuppressive agents
- Patients known to have HIV infection and/or on anti-retroviral agents
- Patients with typical clinical features suggestive of T1DM (young onset with no family history of diabetes or first presentation as DKA were excluded). The endocrinologist (PI or co-I) will look at the patient profile to confirm diagnosis of T2DM.
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 |
|---|---|---|
| DapagliflozinDapagliflozin 10mg tablets | Drug | Dapagliflozin |
| MetFORMIN 500 Mg Oral TabletMetformin 500 mg tablets twice daily | Drug | Metformin |
| Dapagliflozin / metFORMIN PillCombination pill | Drug | MetforminXR 500/Dapagliflozin 5mg |
Primary outcome
Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)
Time frame: 3 months after initiation
Carotid Femoral Pulse Wave Velocity
Time frame: 3 months after initiation
Sphygmocor determined cf-PWV
3 secondary outcomes
Augmentation index
Time frame: 3 months after initiation
Central pulse pressure
Time frame: 3 months after initiation
Advanced glycation end products
Time frame: 3 months after initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Derived from this study: PubMed 42396722Chee YJ, Acharyya S, Liew H, Seow CJ, Goh LL, Boehm BO, Dalan R. First-Line Dapagliflozin, Metformin, or Combination Therapy in Type 2 Diabetes: Vascular and Molecular Outcomes of a Randomised Controlled Trial. Diabetes Obes Metab. 2026 Jul 3. doi: 10.1111/dom.71056. Online ahead of print.
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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.
Siti Zaidah contact
Rinkoo Dalan principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin, MetFORMIN 500 Mg Oral Tablet and Dapagliflozin / metFORMIN Pill in people with Diabetes, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Jul 2022. 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 Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinkoo Dalan, MBBS (63571000, rinkoo_dalan@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT) (time frame: 3 months after initiation). The study lists 2 primary outcomes in all. 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 NCT05440591, 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 1 Jul 2022.