Intraclass Safety and Efficacy Comparison Among SGLT-2 Inhibitors in Elderly Patients With Type 2 Diabetes. A Pragmatic, Phase IV, Multicenter, Open-label, Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,167
- 主要终点
- Primary Objective
研究概览
简要总结
Three SGLT2i were commercially available in Italy at the time the trial was designed: canagliflozin, dapagliflozin, and empagliflozin. Preliminary evidence suggests that the higher dose canagliflozin (300 mg/day) might exert a stronger glucose-lowering effect than dapagliflozin or empagliflozin. The clinical relevance of this putative difference is however unknown. On the other side, the use of canagliflozin, but not empagliflozin and dapagliflozin, has been associated with an increased risk of some adverse events, namely bone fractures and lower limb amputations. Currently, the available information on the efficacy and safety of SGLT2i in elderly (70+ years) patients with type 2 diabetes are is very scant. Thus, a compelling need now exists of comparing efficacy and safety of the commercially available SGLT2i in a population of frail patients at high risk of cardiovascular and renal diseases.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Age 70+ years
- •Male or female
- •Prevalent cardiovascular disease (symptomatic or asymptomatic) or eGFR <90 ml/min/1.73 m2 and above the lower limit for initiation of SGLT2i according to label (currently eGFR <60 ml/min/1.73 m2)
- •HbA1c above individualized target
- •Indication to add SGLT2i
排除标准
- •Age >90 years
- •Estimated life expectancy <1 year
- •Very high risk of genitourinary tract infections (>2 events in the last 6 months)
- •Recent weight loss (>5% in <6 months)
- •Inability to provide informed consent
研究组 & 干预措施
canagliflozin
100 mg (or 50/850 mg and 50/1000 mg of the fixed association with metformin) or 300 mg (or the 150/850 mg and the 150/1000 mg fixed association with metformin).
干预措施: Canagliflozin (Drug)
dapagliflozin
10 mg (or 5/850 mg and 5/1000 mg of the fixed association with metformin; or 10/5 mg of the fixed dapagliflozin / saxagliptin combination)
干预措施: Dapagliflozin (Drug)
empagliflozin
10 mg (or 5/850 mg and 5/1000 mg of the fixed association with metformin; or 5/5 mg of the empagliflozin / linagliptin combination) or 25 mg (or the 12.5/850 mg and the 12.5/1000 mg fixed association with metformin; or the 12.5/5 mg empagliflozin / linagliptin combination).
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Primary Objective
时间窗: Up to 24 months
The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-2 hypoglycaemia.
次要结局
- Secondary Objectives - HbA1c(Up to 24 months)
- Secondary Objectives - body weight(Up to 24 months)
- Secondary Objectives - medications(Up to 24 months)
- Secondary Objectives - treatment satisfaction(Up to 24 months)
- Secondary Objectives - biomarkers(Up to 24 months)
- Secondary Objectives - systolic blood pressure(Up to 24 months)
- Secondary Objectives - e-GFR(Up to 24 months)
- Secondary Objectives - urinary albumin excretion rate(Up to 24 months)