NCT04272359

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas	Substitution of sulfonylureas with other classes of new hypoglycaemic drugs. In every group, it will be evaluated: * efficacy in terms of glycometabolic compensation (glycemia, HbA1c, lipid profile); * effects on BMI, blood pressure monitoring and hypoglycemic risk; * changes in renal function and microalbuminuria; * tolerability and side effects of the new therapeutic regimes; * therapeutic adherence; * post-prandial glycemic excursion, determined by a 6-point glycemic diary (pre- and 2h post-prandial glucose values) to be performed at home in the week before the scheduled follow-up visit; * effects on chronic complications of diabetes and cardiovascular safety.

Timeline

• Start date: 2019-05-06
• Primary completion: 2021-10-06
• Completion: 2021-12-31
• First posted: 2020-02-17
• Last updated: 2021-09-28

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study