Observational Retrospective Cohort Study to Evaluate the Benefits, Documented in Experimental Settings, of Treatment With DAPAGLIFLOZIN in Normal Clinical Practice, in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment
研究概览
简要总结
The aim of the study is to evaluate the benefits, documented in experimental settings, of treatment with Dapagliflozin in subjects with type 2 diabetes in normal clinical practice.
The type of study does not involve immediate risks or direct benefits for the subjects taking part in it. The potential benefits for clinicians and healthcare systems are: greater knowledge of diabetic disease and the study of new treatment options. However, the analysis of the data will allow us to better identify which patients benefit most from treatment with Dapagliflozin.
详细描述
An observational, multicentric, non-interventional, non-profit, single-arm, retrospective prospective study is proposed, aimed at investigating the therapeutic efficacy at 4 months of a treatment with Dapagliflozin® in subjects with type 2 diabetes mellitus belonging to the Lombard centers who joined the study.
Patient recruitment will be carried out at the Unit of Endocrine Diseases and Diabetology in the L. Sacco, Fatebenefratelli and Oftalmico e Macedonio Melloni hospitals, directed by Prof. Paolo Fiorina. Upon enrollment, the informed consent signed and dated by the doctor who informed the patient and by the patient himself will be collected as well as the patient's medical and anamnestic data. This study does not foresee that additional diagnostic or monitoring procedures will be implemented on patients outside of normal clinical practice. The duration of the study per patient after enrollment is 6 months.
This study involves the collection of retrospective data (review of patient medical records). The collection of retrospective data will be done to study the clinical characteristics of the patients at the time they started Dapagliflozin®. The study aims to compare the results reported in the literature with the efficacy outcomes in real-life; to this end, the main clinical and biometric parameters of adult patients with type 2 diabetes belonging to the centers that have joined the study and have been on therapy with Dapagliflozin® for at least 4 months will be collected.
By compiling an online database, the parameters and the respective 4-month variations will be entered anonymously and processed in an aggregate manner in compliance with current regulations and regulatory activities for the conduct of observational retrospective studies.
The insertion of the observations will end after 6 months from the authorization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type II diabetes mellitus, according to ADA indications for at least 3 months
- •Males or females> 18 years old
- •Stable therapy for at least 3 months with oral hypoglycemic agents / insulin
- •Prescription of Dapagliflozin®, according to normal clinical practice and local indications for the prescription / reimbursement of the drug.
排除标准
- •Mental incapacity, unavailability or language barriers that preclude adequate understanding or cooperation;
- •Diagnosis of type 1 diabetes mellitus, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), gestational diabetes mellitus, secondary diabetes mellitus or any other hyperglycemic state other than type 2 diabetes (T2D);
- •Women who are pregnant or breastfeeding, or women planning to become pregnant;
- •Previous participation in the study. Participation is defined by having given informed consent to the study;
- •Participation in another clinical study on T2D that includes any clinical intervention or administration of an investigational drug within 3 months prior to enrollment in the study;
研究组 & 干预措施
Treatment group
Patient in treatment with Dapagliflozin 10 mg/day
干预措施: Dapagliflozin 10mg (Drug)
结局指标
主要结局
Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment
时间窗: From baseline to 4 months
次要结局
- Assessment of the change in fasting glycemic control (mg/dl)(From baseline to 4 months)
- Evaluation of Body Mass Index (BMI) (kg/m2)(From baseline to 4 months)
- Evaluation of hip and waist circumferences (cm)(From baseline to 4 months)
- Evaluation of systolic and diastolic blood pressure (mmHg)(From baseline to 4 months)
- Evaluation of glomerular filtration rate (GFR) (ml/min/1.73m2)(From baseline to 4 months)
- Evaluation of albuminuria (mg/g creatinine)(From baseline to 4 months)
研究者
Paolo Fiorina, MD
Professor
University of Milan