Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs

Status Recruiting

Clinical Trial 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)

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04272359
Study type	Observational [Patient Registry]
Source	University of Milan
Contact	Maria Elena Lunati, MD
Phone	02 63632256
Email	mariaelena.lunati@asst-fbf-sacco.it
Status	Recruiting
Phase
Start date	May 6, 2019
Completion date	December 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06111040` - Nurturing Needs Study: Parenting Food Motivated Children	N/A
Completed	`NCT06299072` - A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast
Recruiting	`NCT05863559` - Super Chef - an Online Program Promoting the Mediterranean Dietary Pattern to Lower Income Families	N/A
Active, not recruiting	`NCT04583683` - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities	N/A
Not yet recruiting	`NCT05934968` - Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes	N/A
Not yet recruiting	`NCT05783141` - Prebiotic Effects in Healthy Toddlers	N/A
Active, not recruiting	`NCT05544461` - Piloting a Web-based Personalised Nutrition App (eNutri) With UK University Students	N/A
Active, not recruiting	`NCT04991142` - Models of Nutrition From Continuous Glucose Monitors
Recruiting	`NCT04946448` - COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study	N/A
Not yet recruiting	`NCT06464497` - Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity	N/A
Completed	`NCT04084028` - Cooking as a Health Behavior in College Students	N/A
Terminated	`NCT04067362` - Chicory Fiber Effect on Satiety and GI Tolerance	N/A
Recruiting	`NCT05512247` - Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy	N/A
Recruiting	`NCT06145009` - Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women	N/A
Recruiting	`NCT06022302` - Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism	N/A
Completed	`NCT05173376` - SEP and the Impact of Portion Size on Daily Energy Intake	N/A
Recruiting	`NCT04374747` - Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk	N/A
Recruiting	`NCT04876053` - Home Food Delivery for Diabetes Management in Patients of Rural Clinics	N/A
Not yet recruiting	`NCT06298253` - Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2	N/A
Not yet recruiting	`NCT05566587` - Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms