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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.
Full 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.
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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.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups
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Central trial contact
Rinkoo Dalan, MBBS; Siti Zaidah
Data sourced from clinicaltrials.gov
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