Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Long-term diabetes complications
研究概览
简要总结
This is a multicentric, prospective, parallel groups study. Patient recruitment will be carried out at the U.O. Departmental Endocrinology and Diabetology ASST FBF Sacco, Fatebenefratelli and Ophthalmic Hospital, and at the SSD of Endocrine Diseases and Diabetology ASST FBF Sacco, L. Sacco Hospital.
At the screening visit, patients being treated with sulfonylureas / glinids will be shifted, depending on the subject's biochemical and phenotypic characteristics, based on current prescribing criteria and diabetes complications, to one of 4 different types of treatment:
- GROUP 1: SGLT2 inhibitors +/- Metformin
- GROUP 2: DPP4 inhibitors +/- Metformin
- GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin
- GROUP 4: SGLT2 inhibitors + DPP4 inhibitors +/- Metformin At the screening visit the clinician will evaluate which new treatment to assign to the patient, based on the subject's biochemical and phenotypic characteristics, current prescribing criteria and existing complications (Algorithm for the treatment of diabetes mellitus, SID-AMD Care Standard 2018)
详细描述
Approximately 500 T2DM patients aged ≥18 years will be enrolled according to the guidelines of the American Diabetes Association (ADA) with poor glycemic control (hemoglobin A1c [A1C] ≥6.5% and ≤11% [≥58 mmol / mol and ≤97 mmol / mol]), in stabilized treatment with sulfonylureas / glinids, which meet all the study enrollment criteria.
During the study 7 visits are scheduled which coincide with the routine diabetic visits.
During the scheduled visits the patients of the study will be subjected to:
- Enrollment on the first visit if the inclusion criteria are met and those of exclusion are absent
- Anamnestic and clinical collection
- Evaluation of the type of treatment to which they have been assigned and possible modification of drug therapy in the in case that the desired glycemic target has not yet been reached up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years;
- •6.5% <HbA1c <11%;
- •Diagnosis of type 2 diabetes mellitus;
- •Active treatment with sulfonylureas / glinids, both in monotherapy and in association with other long-acting hypoglycemic / insulins.
- •Written informed consent of the patient or a legal guardian signed and dated
排除标准
- •Patients suffering from severe systemic diseases, fever, known chronic inflammatory states
- •PCR determinants> 10 mg/L;
- •HbA1c> 11% or HbA1c <6.5%;
- •Use of corticosteroids at the time of enrollment;
- •Poor patient understanding of spoken and written Italian;
- •Absent compliance.
结局指标
主要结局
Long-term diabetes complications
时间窗: 12 months
Evaluation of the effect of new generation hypoglycemic drugs on the long-term complications of diabetes compared to the effect obtained with sulphonylureas
Therapeutic adherence
时间窗: 12 months
Assessment of adherence to the doctor's prescription of new generation hypoglycaemic drugs
Concentration of the glyco-metabolic parameters
时间窗: 12 months
Evaluation of the new generation hypoglicemic drugs on Hba1c, blood glucose, lipidic profile
次要结局
- Therapeutic compliance, even in populations over 70 years.(12 months)
- Values of the insulin-sensitivity(12 months)
- Insulin parameters after shift to new-generation hypoglycaemic therapeutic regimens(12 months)
研究者
Paolo Fiorina, MD
Clinical Professor
University of Milan