2024-518915-20-00招募中4 期
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.
Center For Outcomes Research And Clinical Epidemiology S.r.l.27 个研究点 分布在 1 个国家目标入组 1,167 人开始时间: 2024年11月13日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,167
- 试验地点
- 27
- 主要终点
- Glucose control without level-3 hypoglycemia
研究概览
简要总结
The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-3 hypoglycaemia at the end of the study at 24 months0
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow up
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Age >=70 years
- •Men or women
- •Established cardiovascular disease (symptomatic or asymptomatic) or eGFR <90 ml / min / 1.73 m2 but above the threshold for starting therapy with all SGLTe inhibitors
- •HbA1c higher than the individualized target value
- •Clinical indication when starting a therapy with SGLT2i
- •Ability to give written informed consent.
排除标准
- •Age> 90 years
- •Estimated life expectancy <1 year
- •Very high risk of urinary infections (more than 2 episodes in the last 6 months)
- •Recent unintentional weight loss (> 5% in <6 months)
- •Participation in another interventional drug trial
- •Inability to give written informed consent
- •Intolerance to lactose and any other contraindication to the study drugs
结局指标
主要结局
Glucose control without level-3 hypoglycemia
Glucose control without level-3 hypoglycemia
次要结局
- Glucose control without level-2 hypoglycemia
- Change in HbA1c glycemic and extraglycemic endpoints
- Change in HbA1c
- Change in body weight
- Change in systolic blood pressure
- Change in eGFR
- Change in the use of concomitant medications
- Change in the dosage of concomitant medications
- Change in treatment satisfaction
- Safety: - Hospitalization for any cause, - Hospitalization for heart failure, - Hospitalization for cardiovascular causes, - All-cause death - Cardiovascular death - Severe hypoglycemia - Genitourinary tract infections - Dehydration / hypovolemia events - Bone fractures; - Leg/foot amputations - Diabetic ketoacidosis
研究者
Antonio Nicolucci
Scientific
Center For Outcomes Research And Clinical Epidemiology S.r.l.
研究点 (27)
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