Prospective Observational Cohort Study to Evaluate the Benefits, Documented in the Experimental Settings, of Treatment With SGLT2-i in Normal Clinical Practice, in Subjects With Type 2 Diabetes and Older Than 70 Years.
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Variation in HbA1c values (% -point)
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 SGLT2-i in subjects with type 2 diabetes and older than 70 years 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 glycosurics.
详细描述
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) may have important benefits for the elderly with type 2 diabetes (T2D), however some safety concerns still limit their use in patients over 70 years of age. The SOLD study (SGLT2-i in Older Diabetic patients) aim to evaluate which basal characteristics of the patients are more frequently related to the suspension of treatment with SGLT2-i in a real-life setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent issued before any other activity related to the study (i.e. any activity related to data collection according to the study protocol);
- •Diagnosis of type II diabetes mellitus, according to ADA indications for at least 3 months
- •Males or females > 70 years old
- •Stable therapy for at least 3 months with oral hypoglycemic agents / insulin
- •Prescription of SGLT2 inhibitors, in accordance with normal clinical practice and local drug prescription / reimbursement guidelines.
排除标准
- •Mental incapacity, unavailability or language barriers that preclude adequate understanding or cooperation;
- •Diagnosis of type 1 diabetes mellitus, MODY (maturity-onset diabetes of the young), LADA (latent autoimmune diabetes in adults), gestational diabetes mellitus, secondary diabetes mellitus or any other hyperglycemic state other than T2D;
- •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
结局指标
主要结局
Variation in HbA1c values (% -point)
时间窗: From Baseline to 12 months
Variation in HbA1c values (% -point) from baseline to 12 months from enrollment
次要结局
- Evaluation of fasting glycemic control(From Baseline to 12 months)
- Evaluation of the weight(From Baseline to 12 months)
- Evaluation of the BMI(From Baseline to 12 months)
- Evaluation of the heart rate(From Baseline to 12 months)
- Evaluation of the maintenance of glycemic compensation(From Baseline to 12 months)
- Evaluation of the systolic and diastolic pressure(From Baseline to 12 months)
- Evaluation of the waist circumference(From Baseline to 12 months)
- Evaluation of the serum creatinine(From Baseline to 12 months)
- Evaluation of the main side effects and the withdrawal rate(From Baseline to 12 months)
- Evaluation of the e-GFR(From Baseline to 12 months)
研究者
Paolo Fiorina, MD
Principal Investigator
University of Milan