Phase 4 Type 2 Diabetes Trial, Recruiting NCT06983054 Sponsor: Amsterdam UMC, location VUmc Condition: Type 2 Diabetes
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Phase 4 Type 2 Diabetes Trial, Recruiting

NCT06983054
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:

  • Adults who have previously been diagnosed with Type 2 diabetes, based on standard diagnostic guidelines
  • People whose HbA1c (a measure of average blood sugar over time) is between 6.5% and 10%
  • People aged between 18 and 85 years old
  • People who are overweight or obese, with a BMI greater than 25
  • People of any race or ethnicity — the trial team will make every effort to include a diverse range of participants
  • Both men and women are eligible; women must have gone through menopause, meaning no periods for more than one year (a hormone blood test may be used to confirm this if there is any uncertainty)
  • People who are able and willing to sign a written consent form before any study procedures begin
  • People whose kidney filtering function (eGFR) falls within the range of 60–90 ml/min/1.73m², as measured by a specific kidney health calculation
  • People whose daily salt (sodium) intake at the start of the study is below a certain level (confirm with trial site)
  • People whose urine protein levels (UACR) are below 30 mg/mmol, indicating no significant protein leakage into the urine
  • People who are already taking a stable, unchanged dose of diabetes medication, such as Metformin, sulfonylureas, DPP4-inhibitors, or insulin
  • People with high blood pressure who are already on a stable dose of blood pressure medication that works on the RAS (renin-angiotensin system), or another stable blood pressure treatment if that type is not tolerated

Who may not be able to join:

  • People with a history of unstable or rapidly worsening kidney disease
  • People whose kidney filtering function (eGFR) is below 60 or above 90 ml/min/1.73m²
  • People whose urine protein levels (UACR) are above 30 mg/mmol
  • People currently or regularly taking any of the following medications: SGLT2 inhibitors, thiazolidinediones (TZD), GLP-1 receptor agonists, steroids (glucocorticoids), immune-suppressing drugs, antibiotics, or chemotherapy drugs; people on certain antidepressants or antipsychotics must be on a stable dose; people on water tablets (diuretics) may be excluded unless those tablets can be safely stopped for the study period
  • People who regularly take anti-inflammatory painkillers (such as ibuprofen); occasional use for short-term issues like headaches or sports injuries may be acceptable, but none can be taken within two weeks before kidney testing
  • People who have had a serious diabetic emergency (diabetic ketoacidosis requiring an emergency room visit or hospital stay) within the month before screening
  • People with a current urinary tract infection or active kidney inflammation
  • People who have had a significant heart or blood vessel event in the past six months, including a heart attack, moderate-to-severe heart failure, stroke, or a temporary stroke-like episode
  • People with severe liver disease or significantly abnormal liver test results
  • People with an active cancer diagnosis; a past history of cancer may be acceptable unless the person is still receiving treatment other than hormone therapy
  • People with a history of, or currently experiencing, severe mental illness
  • People who drink more than four units of alcohol per day
  • People who are allergic to any of the medications or substances used in the study
  • People who work at the trial site or who are close family members of someone who does
  • People who are unable to understand the study instructions or provide informed consent

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 9 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
Amsterdam UMC, location VUmc
Registry
ClinicalTrials.gov
Start date
25 July 2023
Est. completion
1 December 2025

Where this trial is recruiting

🇳🇱 Netherlands 🇺🇸 United States

Primary endpoints

Blood pressure

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: 9 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