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Taking people in ItalyPhase 4

Tests two diabetes medicines in adults with type 2 diabetes grouped by biomarkers

Compares dapagliflozin and oral semaglutide in adults with type 2 diabetes.

Key facts

Who runs it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Where
Bari and Rome, ItalySee the 2 sites
Registry title
Searching simple biomarkers to phenotype type 2 diabetic patients and personalize their treatment
Status
Recruiting
Phase
Phase 4
People taking part
148 people, planned
Started
8 Jul 2025
Planned end
1 Nov 2026
Type of study
Interventional
Record updated
27 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes who take metformin and whose blood sugar is still not well controlled. It compares dapagliflozin and oral semaglutide.

Age
20 – 80 years old (the registry also lists a minimum age of 18 years)
Sex
Men and women
Disease stage
Type 2 diabetes with suboptimal glycemic control (HbA1c ≥6.5 % (48 mmol/mol)) and fasting C-peptide > 1 ng/mL (0.33 nmol/L)
Earlier treatment
Stable therapy with metformin for at least 6 months. No other anti-diabetic drugs besides metformin. No steroid therapy within the last 3 months.
Biomarker or test result
HbA1c ≥6.5 % (48 mmol/mol); fasting C-peptide > 1 ng/mL (0.33 nmol/L). GAD-Ab positivity excludes people.

Main reasons for not taking part

  • Type 1 diabetes or LADA
  • Severe liver dysfunction or severe renal dysfunction (eGFR < 25 ml/min/1.73m2)
  • History of pancreatitis, or altered levels of amylase and lipase
  • Pregnant or breast-feeding women
  • Severe obesity (BMI > 40)

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico Di BariBari, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Searching simple biomarkers to phenotype type 2 diabetic patients and personalize their treatment
Plain-language title
Tests two diabetes medicines in adults with type 2 diabetes grouped by biomarkersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
27 April 2026