Type 1 Diabetes Trial, Recruiting NCT06092476 Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Condition: Type 1 Diabetes
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Type 1 Diabetes Trial, Recruiting

NCT06092476
Recruiting Not Applicable

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
  • People between 18 and 75 years of age
  • People who have never used insulin, and who have been taking a stable dose of 2 or more blood sugar-lowering medications (such as metformin, sulphonylurea, SGLT-2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or thiazolidinediones) for at least 12 weeks
  • People with a Body Mass Index (BMI) between 24 and 40
  • People whose long-term blood sugar level (HbA1c) falls within a specific range — between 7.5% and 10.0% (confirm exact values with trial site)
  • People who have read, understood, and signed a consent form agreeing to take part in the trial

Who may not be able to join:

  • People whose fasting blood sugar is very high (above 15.0 mmol/L) after an overnight fast, confirmed on two separate days
  • People who are currently using insulin
  • People whose body shows very little or no natural insulin production, based on a specific blood test result (C-peptide below 0.2 nmol/L)
  • People diagnosed with Type 1 diabetes, autoimmune diabetes (including LADA), or a rare genetic form of diabetes (such as MODY or neonatal diabetes)
  • People who have had more than one severe low blood sugar episode in the past 6 months where they needed help from another person
  • People with a significant heart valve problem or severe narrowing of the aortic valve
  • People who have had a heart attack, unstable chest pain, stroke, or mini-stroke in the past 3 months
  • People with signs of significant liver damage, based on specific blood test results
  • People with active hepatitis B or C (unless hepatitis C has been fully cured), liver cirrhosis, liver failure in the past 6 months, or alcoholic or autoimmune liver disease
  • People with significantly reduced kidney function, kidney failure, or who are on dialysis
  • People diagnosed with a swallowing disorder affecting the food pipe, or with severe acid reflux disease (grade 3 or higher), or where this is found during a screening examination
  • People with a known structural or functional stomach problem, such as a stomach ulcer, chronic gastritis, stomach varicose veins, hiatal hernia, or stomach cancer
  • People who have had certain types of stomach or bowel surgery in the past, such as gastric bypass, gastric sleeve, or similar procedures
  • People with an autoimmune condition affecting the intestines, such as coeliac disease, or conditions such as lupus or scleroderma that affect the small intestine
  • People with a current active Helicobacter pylori stomach infection (people who were previously treated successfully for this infection may still be considered)
  • People with an active cancer diagnosis or who have been in partial remission from a significant cancer in the past 5 years (some exceptions may apply — confirm with trial site)
  • People with blood disorders that cause the breakdown of red blood cells or that make red blood cells unstable
  • People with severe disease affecting the blood vessels in the arms or legs
  • People with an active widespread infection in the body
  • People with a weakened immune system, including those who have had an organ transplant, chemotherapy, or radiotherapy in the past 12 months, those with significantly low white blood cell counts, those who are HIV positive, or those taking medications that suppress the immune system
  • People currently taking long-term steroid medications, or who have had a change in their thyroid hormone medication within the past 6 weeks, or who have another uncontrolled hormone-related condition
  • People taking blood-thinning medications (such as warfarin, newer anticoagulants, or certain anti-platelet drugs) that cannot safely be stopped for 5–7 days before the procedure (aspirin does not need to be stopped)
  • People who are currently enrolled in a weight loss program or who have used weight loss medications in the 3 months before joining the trial
  • People for whom sedation or general anaesthesia would not be safe, or who are considered high risk for an internal stomach examination (endoscopy)
  • People who are pregnant, breastfeeding, or who are able to become pregnant and are not willing to use an acceptable form of contraception during the trial
  • People with a history of alcohol, legal drug, or illegal drug misuse
  • People who have taken part in another clinical trial using an experimental drug or device within the past 30 days, or who are currently active in another such trial
  • People with any other medical or mental health condition that the trial team considers would affect their safety or suitability for the trial

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 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jacques JG Bergman, MD, PhD, Amsterdam UMC

Phone: +31621357593

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Registry
ClinicalTrials.gov
Start date
9 August 2024
Est. completion
1 January 2027

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Safety endpoint; Feasibility endpoint 1; Feasibility endpoint 2; Efficacy endpoint 1; Efficacy endpoint 2

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: 26 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