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

NCT04272359 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2021-09-28

No results posted yet for this study

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)

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Paolo Fiorina, MD, PhD · University of Milan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2021-10-06
Completion
2021-12-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272359 on ClinicalTrials.gov