Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus (Sulfa-Zero)

University of Milan

Status: Unknown

Conditions: Albuminuria; Diet, Healthy; Renal Function Disorder; T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas

Study type: Observational

Funder types: Other

Identifiers

NCT04272359

Sacco Milan

Details and patient eligibility

About

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:

1. GROUP 1: SGLT2 inhibitors +/- Metformin
2. GROUP 2: DPP4 inhibitors +/- Metformin
3. GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin
4. 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)

Full description

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

138 participants in 4 patient groups

Group 1

Description:

SGLT2 inibitori +/- Metformin

Treatment:

Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas

Group 2

Description:

DPP4 inibitori +/- Metformin

Treatment:

Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas

Group 3

Description:

GLP1-RA + Long-Acting Insulin +/- Metformin

Treatment:

Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas

Group 4

Description:

SGLT2 inibitori + DPP4 inibitori +/- Metformin

Treatment:

Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas