Status:
UNKNOWN
Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus
Lead Sponsor:
University of Milan
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Diet, Healthy
Eligibility:
All Genders
18+ years
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 Ophthalm...
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%...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04272359
Start Date
May 6 2019
End Date
December 31 2021
Last Update
September 28 2021
Active Locations (1)
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1
ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico
Milan, Italy, 20157