forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers
研究概览
简要总结
The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control
详细描述
Observational Model: Other: A post-marketing evaluation of the safety of Forxiga through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes who are:
- •Prescribed Forxiga for glycaemic management AND
- •Who have the ability to provide informed consent
排除标准
- •Patients with whom use of Forxiga is contraindicated:
- •Patients with Type 1 Diabetes
- •Patients with moderate to severe renal impairment [Creatinine clearance (CrCl) <60 mL/min or estimated glomerular filtration rate (eGFR) <60mL/min/1.73m²]
- •Additional exclusion criteria:
- •Age >75 years
- •Concomitant use of loop diuretics or pioglitazone
- •Patients who are currently on another SGLT2 inhibitor
研究组 & 干预措施
T2DM patients newly prescribed Forxiga
A post-marketing evaluation of the safety of Forxiga (10 mg tablets, orally once daily for 6 months) through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice.
干预措施: Forxiga (Drug)
结局指标
主要结局
Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers
时间窗: Up to 6 months
Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
Any early adverse effects as a result of drug interactions in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
时间窗: Up to 6 months
Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
时间窗: Up to 6 months
次要结局
- Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice(Upto 6 months)
- Indication for prescription of Forxiga in routine Australian clinical practice(Upto 6 months)
- Change in efficacy and safety variables after treatment with Forxiga for at least 3 months(Baseline and 3 months)
- Subgroup analyses may be conducted for selected safety parameters(Upto 6 months)