Phase 4 Type 2 Diabetes Trial, Recruiting NCT06613854 Sponsor: University Medical Centre Ljubljana Condition: Type 2 Diabetes
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Phase 4 Type 2 Diabetes Trial, Recruiting

NCT06613854
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with type 2 diabetes for 2 years or less before the trial start date
  • People aged between 18 and 70 years, of any sex, race, or ethnicity
  • People whose HbA1c (a blood sugar control measure) is at or below 8.0% at the time of joining
  • People who are already taking metformin at a stable daily dose of at least 1500 mg
  • People who have signed a consent form agreeing to take part in the study

Who may not be able to join:

  • People who have ever taken certain diabetes medications known as SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors
  • People who have used insulin for more than 2 weeks at any point in the past
  • People whose Body Mass Index (BMI) is below 22 or above 40
  • People with moderate to advanced kidney disease or significant protein in their urine (confirm with trial site)
  • People with a known history of heart disease, including angina, heart attack, heart failure, or artery disease
  • People with moderate or severe liver disease
  • People with a personal history of pancreatitis (inflammation of the pancreas)
  • People with advanced heart failure
  • People with eye disease related to diabetes, such as retinopathy or maculopathy, or who are currently being treated for these conditions
  • People who are pregnant, planning to become pregnant, or breastfeeding
  • People with an active cancer diagnosis, or a cancer diagnosis within the past 5 years
  • People with a personal history of thyroid cancer, or a personal or family history of certain inherited hormone-related conditions (multiple endocrine neoplasia type 2 or medullary thyroid carcinoma)
  • People with chronic inflammatory bowel disease
  • People who have had bariatric (weight loss) surgery or other gut surgery that could affect how the body absorbs food or medication
  • People who experience frequent or severe urinary tract infections
  • People who use a urinary catheter
  • People who experience recurring or troublesome genital fungal infections
  • People with a personal history of ketoacidosis (a serious condition where the blood becomes too acidic)
  • People who have low blood pressure symptoms or are prone to dehydration
  • People who have had an organ transplant
  • People with a known allergy to any ingredient in the study medications (semaglutide or empagliflozin oral tablets)
  • People whose personal, medical, or social circumstances may make it difficult to attend regular study visits
  • People with any other condition that the trial investigators consider may affect their safety or how well the treatment works

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
University Medical Centre Ljubljana
Registry
ClinicalTrials.gov
Start date
1 October 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇸🇮 Slovenia

Primary endpoints

Time in Range (TIR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov