SEMAGLUTIDE for Type 2 diabetes

Stratification factors

• Prevalent insulin resistance (IR) vs prevalent insulin secretion deficit (ISD) phenotype

Inclusion criteria

• {"criterion_text":"- Provision of informed consent prior to any study specific procedures\n- Will and ability to comply with the protocol\n- Age: 20 – 80 years old\n- Sex: Males and Females\n- Stable therapy with metformin for at least 6 months\n- Suboptimal glycemic control (HbA1c ≥6.5 %)\n- Fasting C-peptide > 1 ng/mL (0.33 nmol/L)\n- Women of childbearing potential must have a negative blood or urine pregnancy test at the baseline visit\n- Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.9 of the protocol\n- Ability to take oral medications"}

Exclusion criteria

• {"criterion_text":"- Previous type 1 diabetes or Late-Onset Autoimmune Diabetes of the Adult (LADA) diagnosis, as assessed by medical history\n- Inability to provide informed consent\n- History of diabetic ketoacidosis or hyperosmolar non ketotic coma\n- Concomitant anti-diabetic drugs other than metformin\n- Steroidal therapy within the last 3 months\n- Medications known to significantly impact glucose metabolism (e.g., atypical antipsychotics)\n- GAD-Ab positivity\n- Severe obesity (BMI > 40)\n- Altered levels of amylase and lipase\n- Severe liver dysfunction\n- history of pancreatitis, patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption\n- Severe renal dysfunction (eGFR < 25 ml/min/1.73m2)\n- Uncontrolled hypertension\n- Uncontrolled dyslipidemia (total cholesterol > 300 mg/dl and/or LDLc > 200 and/or triglycerides > 500 mg/dl)\n- Known hypersensitivity to the active substance or to any of the excipients in study drug\n- Pregnant or breast-feeding women\n- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of nonchildbearing potential\n- Treatment with hormonal contraception\n- Frailty in elderly participants aged > 75 years, defined as: severe comorbidities associated with limited life expectancy; or Clinical Frailty Scale (CFS) > 5; or cognitive impairment interfering with treatment adherence."}

Primary endpoints

• {"endpoint_text":"- To assess the differential effects of treatment with semaglutide vs dapagliflozin on metabolic compensation and beta-cell function – measured through glycated hemoglobin (HbA1c)","definition_or_measurement_approach":"Measured through glycated hemoglobin (HbA1c)"}

Secondary endpoints

• {"endpoint_text":"- To verify the ability of biomarkers to offer a signature for patients’ phenotyping even after treatment with dapagliflozin or semaglutide","definition_or_measurement_approach":"Not specified in the provided record"}
• {"endpoint_text":"- To verify the ability of biomarkers to guide the more appropriate choice between dapagliflozin or semaglutide treatments in well-distinguished phenotypes of diabetic patients","definition_or_measurement_approach":"Not specified in the provided record"}

Italy

Earliest CTIS Part Ii Submission Date

25-09-2024

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

579

Number Of Sites

2

Number Of Participants

148

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Azienda Ospedaliera Universitaria Federico II Di Napoli","duties_or_roles":"nutritional assessment","organisation_type":"Hospital/Clinic/Other health care facility"}