Phase 3 Type 1 Diabetes Trial, Recruiting
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:
- You must be willing and able to sign a consent form agreeing to take part in the study.
- You must be male or female, aged 40 or older, and have had Type 1 diabetes for more than 10 years (diagnosed before age 30 with insulin used from the start, or if diagnosed after 30, insulin used from the start along with a diabetic emergency called DKA or positive diabetes-related blood markers).
- You must have at least one of the following: signs of kidney disease (based on specific urine or blood test results), a history of heart attack, stroke, or chest pain (angina), a history of heart failure, a BMI over 35, or a calculated 10-year heart disease risk above 10% using a specific calculator called the Steno Type 1 Risk Engine (confirm with trial site).
- If you are a woman who could become pregnant, you must use a highly effective form of contraception throughout the study and for at least 2 months after finishing — approved methods include IUDs, hormonal birth control (pills, implants, patches, vaginal ring, or injections), or you must be post-menopausal, have had both ovaries removed, or have been sterilised or had a hysterectomy at least 12 months before joining.
- You must be able to communicate with the study team and understand what you are agreeing to.
Who may not be able to join:
- You have Type 2 diabetes, a rare genetic form of diabetes (MODY), or diabetes caused by another medical condition.
- You have a history of pancreatitis (inflammation of the pancreas).
- Your BMI is below 18.5 (considered underweight).
- You are a woman who could become pregnant and are currently pregnant, breastfeeding, planning to become pregnant, or not using adequate contraception.
- You have a known or suspected problem with alcohol or recreational drug use.
- You are currently taking part in another clinical intervention study.
- You have very advanced kidney disease (known as CKD stage 5) (confirm with trial site).
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.
Contact this trial
Principal Investigator: Peter Rossing, MD, DMSc, Proffessor, Steno Diabetes Center Copenhagen
Phone: +4521623779
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
Where this trial is recruiting
Primary endpoints
MACE + HHF
Can't join this trial?
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.