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

Sponsor
University of Milan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04272359
Collaborator
(none)
138
Enrollment
1
Location
31.9
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
138 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
May 6, 2019
Anticipated Primary Completion Date :
Oct 6, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Group 1

SGLT2 inibitori +/- Metformin

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.
Other Names:
  • Shift to new generation therapeutic regimens

    		•
    Group 2

    DPP4 inibitori +/- Metformin

    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.
    Other Names:
  • Shift to new generation therapeutic regimens

    		•
    Group 3

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

    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.
    Other Names:
  • Shift to new generation therapeutic regimens

    		•
    Group 4

    SGLT2 inibitori + DPP4 inibitori +/- Metformin

    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.
    Other Names:
  • Shift to new generation therapeutic regimens

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of the glyco-metabolic parameters [12 months]

      Evaluation of the new generation hypoglicemic drugs on Hba1c, blood glucose, lipidic profile

    2. Therapeutic adherence [12 months]

      Assessment of adherence to the doctor's prescription of new generation hypoglycaemic drugs

    3. 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

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico Milano Italy 20157

    Sponsors and Collaborators

    • University of Milan

    Investigators

    • Principal Investigator: Paolo Fiorina, MD, PhD, University of Milan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Paolo Fiorina, MD, Clinical Professor, University of Milan
    ClinicalTrials.gov Identifier:
    NCT04272359
    Other Study ID Numbers:
    • Sacco Milan
    First Posted:
    Feb 17, 2020
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Paolo Fiorina, MD, Clinical Professor, University of Milan
    Sulfaniluree/glinidi
    Additional relevant MeSH terms:
    Albuminuria
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Hypoglycemic Agents

    Study Results

    No Results Posted as of Sep 28, 2021