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

NCT04272359 | Unknown FDA Drug

• 1 other identifier: Sacco Milan
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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. 1.GROUP 1: SGLT2 inhibitors +/- Metformin
2. 2.GROUP 2: DPP4 inhibitors +/- Metformin
3. 3.GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin
4. 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

Keywords

Sulfaniluree/glinidi

Outcome Measures

Primary Outcomes (3)

• Concentration of the glyco-metabolic parameters

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

  12 months

• Therapeutic adherence

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

  12 months

• Long-term diabetes complications

  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 Outcomes (3)

• Values of the insulin-sensitivity

  12 months

• Therapeutic compliance, even in populations over 70 years.

  12 months

• Insulin parameters after shift to new-generation hypoglycaemic therapeutic regimens

  12 months

Study Arms (4)

Group 1

SGLT2 inibitori +/- Metformin

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

Group 2

DPP4 inibitori +/- Metformin

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

Group 3

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

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

Group 4

SGLT2 inibitori + DPP4 inibitori +/- Metformin

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

Interventions

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

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.

Also known as: Shift to new generation therapeutic regimens

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age over 18 years;
• % \<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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico

Milan, 20157, Italy

RECRUITING

Related Publications (18)

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  PMID: 15889234 BACKGROUND

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  PMID: 25735400 BACKGROUND

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  PMID: 28497592 BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Albuminuria

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Fiorina, MD, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Elena Lunati, MD

CONTACT

02 63632256; mariaelena.lunati@asst-fbf-sacco.it

Teresa Letizia, Dr.

CONTACT

02 39042648; letizia.teresa@asst-fbf-sacco.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: February 17, 2020
• Study Start: May 6, 2019
• Primary Completion: October 6, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

IT (1)