Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients (SOLDMiDiab02)

University of Milan

Status: Not yet enrolling

Conditions: Type2Diabetes

Treatments: Drug: SGLT2 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05477017

03/2022

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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