2024-516542-19-00RecruitingPhase 4
Searching simple biomarkers to phenotype type 2 diabetic patients and personalize their treatment
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 26 Jul 2024
- Start date
- 8 Jul 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Type 2 diabetes
- EU CT number
- 2024-516542-19-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 148
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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 %) 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 %; 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)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Age
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari | Bari | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.