Searching simple biomarkers to phenotype type 2 diabetic patients and personalize their treatment
Key facts
- Where
- Bari és Rome, OlaszországSee the 2 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliero Universitaria Consorziale Policlinico Di BariBari, OlaszországTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- EU 2024-516542-19-00
- Record updated
- 2026. április 27.
- Original description
To assess responses to different glucose-lowering treatments - dapagliflozin vs oral semaglutide - in patients with T2D categorized into 2 groups, depending on their prevalent insulin resistance (IR) or prevalent insulin secretion deficit (ISD). The differential responses to therapy will be monitored usig a series of non-canonical (e.g., adiponectin, irisin, serpin B1) or canonical biomarkers (HbA1c, glucagon, GLP-1, GIP, insulin, proinflammatory mediators) or other metabolites potentially detected in metabo-lipidomic analysisRead full original descriptionShow less
To assess responses to different glucose-lowering treatments - dapagliflozin vs oral semaglutide - in patients with T2D categorized into 2 groups, depending on their prevalent insulin resistance (IR) or prevalent insulin secretion deficit (ISD). The differential responses to therapy will be monitored usig a series of non-canonical (e.g., adiponectin, irisin, serpin B1) or canonical biomarkers (HbA1c, glucagon, GLP-1, GIP, insulin, proinflammatory mediators) or other metabolites potentially detected in metabo-lipidomic analysis
Inclusion: Provision of informed consent prior to any study specific procedures; Will and ability to comply with the protocol; Age: 20 – 80 years old; Sex: Males and Females; Stable therapy with metformin for at least 6 months; Suboptimal glycemic control (HbA1c ≥6.5 %); Fasting C-peptide > 1 ng/mL (0.33 nmol/L); Women of childbearing potential must have a negative blood or urine pregnancy test at the baseline visit; Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.9 of the protocol; Ability to take oral medications.
Exclusion: Previous type 1 diabetes or Late-Onset Autoimmune Diabetes of the Adult (LADA) diagnosis, as assessed by medical history; Treatment with hormonal contraception; Concomitant anti-diabetic drugs other than metformin; Steroidal therapy within the last 3 months; Uncontrolled hypertension; Known hypersensitivity to the active substance or to any of the excipients in study drug; History of diabetic ketoacidosis or hyperosmolar non ketotic coma; history of pancreatitis, patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; Severe renal dysfunction (eGFR < 25 ml/min/1.73m2); Uncontrolled dyslipidemia (total cholesterol > 300 mg/dl and/or LDLc > 200 and/or triglycerides > 500 mg/dl); Medications known to significantly impact glucose metabolism (e.g., atypical antipsychotics); 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; Severe liver dysfunction; Pregnant or breast-feeding women; 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; Inability to provide informed consent; GAD-Ab positivity; Severe obesity (BMI > 40); Altered levels of amylase and lipase.