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

September 27, 2021 updated by: Paolo Fiorina, MD, University of Milan

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The size of the sample chosen is such in consideration of the average number of patients suffering from type 2 Diabetes Mellitus treated by the Diabetology Clinics of the participating structures in the study and therefore will allow us to complete enrollment within the first months of the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Anticipated)

October 6, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sacco Milan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Albuminuria

Clinical Trials on Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe