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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin XR 500 mg tablets - up-to twice daily orally. |
|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg tablets - once daily |
|
| MetforminXR 500/Dapagliflozin 5mg | Experimental | MetforminXR 500/Dapagliflozin 5mg , tablets- once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin 10mg tablets |
| |
| MetFORMIN 500 Mg Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT) | 3 months after initiation | |
| Carotid Femoral Pulse Wave Velocity | Sphygmocor determined cf-PWV | 3 months after initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Augmentation index | Augmentation index-sphygmocor derived and RHI-endoPAT derived | 3 months after initiation |
| Central pulse pressure | CPP-Sphygmocor derived |
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Inclusion Criteria:
Exclusion Criteria:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rinkoo Dalan, MBBS | Contact | 63571000 | rinkoo_dalan@ttsh.com.sg | |
| Siti Zaidah | Contact | Siti_zaidah_abu_bakar@ttsh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Rinkoo Dalan | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Recruiting | Singapore | 308433 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42396722 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 |
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Open Label Parallel Randomised Controlled Trial
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| Drug |
Metformin 500 mg tablets twice daily |
|
| Dapagliflozin / metFORMIN Pill | Drug | Combination pill |
|
| 3 months after initiation |
| Advanced glycation end products | AGE reader measurements | 3 months after initiation |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |