Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes- A Randomised Controlled Trial (DMVascular Study)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Dapagliflozin
Dapagliflozin 10 mg tablets - once daily
干预措施: Dapagliflozin (Drug)
Metformin
Metformin XR 500 mg tablets - up-to twice daily orally.
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
MetforminXR 500/Dapagliflozin 5mg
MetforminXR 500/Dapagliflozin 5mg , tablets- once daily
干预措施: Dapagliflozin / metFORMIN Pill (Drug)
结局指标
主要结局
Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)
时间窗: 3 months after initiation
Carotid Femoral Pulse Wave Velocity
时间窗: 3 months after initiation
Sphygmocor determined cf-PWV
次要结局
- Augmentation index(3 months after initiation)
- Central pulse pressure(3 months after initiation)
- Advanced glycation end products(3 months after initiation)