Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus

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

• Registration Number: NCT04272359
• Lead Sponsor: University of Milan

Brief Summary

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)

Detailed 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.

Study Timeline

• Study Start: 2019-05-06
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2021-10-06
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term diabetes complications	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	12 months	Assessment of adherence to the doctor's prescription of new generation hypoglycaemic drugs
Concentration of the glyco-metabolic parameters	12 months	Evaluation of the new generation hypoglicemic drugs on Hba1c, blood glucose, lipidic profile

Secondary Outcome Measures

Name	Time	Method
Therapeutic compliance, even in populations over 70 years.	12 months	Evaluation of the effect of new generation hypoglycemic drugs on therapeutic adherence with respect to the effect obtained with sulphonylureas even in older subjects.
Values of the insulin-sensitivity	12 months	Evaluation of the effect of new generation hypoglycemic drugs on the insulin secretion of diabetes compared to the effect obtained with sulphonylureas.
Insulin parameters after shift to new-generation hypoglycaemic therapeutic regimens	12 months	HOMA-IR and HOMA-B% insulin parameters evaluation in patients not in insulin treatment

Trial Locations

Locations (1)

ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico; 🇮🇹 Milano, Italy