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

  • STATUS
    Recruiting
  • End date
    Nov 6, 2021
  • participants needed
    138
  • sponsor
    University of Milan
Updated on 26 January 2021
diabetes
renal function
active treatment

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)

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.

Details
Condition Proteinuria, Albuminuria, Renal Function Disorder, T2DM, Diet, Healthy, Diet, Healthy, Diet, Healthy, Diet, Healthy, Diet, Healthy
Treatment Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas
Clinical Study IdentifierNCT04272359
SponsorUniversity of Milan
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Function Disorder or Proteinuria or Diet, Healthy or T2DM or Albuminuria?
Do you have any of these conditions: Diet, Healthy or Albuminuria or T2DM or Renal Function Disorder or Proteinuria?
Age over 18 years
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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