Phase 2 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have agreed to take part and given your informed consent
• You have been diagnosed with Type 2 diabetes according to standard medical guidelines
• You are 40 years of age or older at the time of joining the study
• You have an abnormal result on a specific heart rate breathing test (called the E/I ratio), based on the average of three measurements (confirm with trial site)

Who may not be able to join:

• You show no signs of a specific nerve condition affecting the heart (called cardiac autonomic neuropathy, or CAN) based on standard tests
• You have been clearly diagnosed with CAN based on more than one abnormal test result
• Your long-term blood sugar level (HbA1c) is above a certain high threshold
• You are taking certain water tablets (such as amiloride, spironolactone, or eplerenone) that cannot be stopped at least 4 weeks before your screening appointment — your own doctor will decide if stopping is possible
• You have a heart rhythm condition called atrial fibrillation or flutter
• You have serious heart failure (a more severe level, known as NYHA class 3 or 4)
• You have a history of irregular heart rhythms (cardiac arrhythmia)
• You have a serious lung condition, including severe asthma or COPD
• Your nerve damage is caused by something other than diabetes
• You are a woman who could become pregnant and either have a positive pregnancy test or are unwilling or unable to use a reliable form of contraception throughout the study
• You have serious liver disease
• You are lactose intolerant
• You are currently breastfeeding
• Your kidneys are so severely affected that you need dialysis
• You are taking beta-blocker medication
• Your blood potassium level is too high at your screening appointment (above 4.8 mmol/l)
• Your kidneys are not working well enough, based on a specific kidney function measurement (eGFR below 25 ml/min/1.73m²)
• Your blood potassium level is still too high at the point of being assigned to a treatment group (above 4.8 mmol/l)
• You are taking certain strong medications that affect how drugs are processed in the body (such as itraconazole, ketoconazole, ritonavir, cobicistat, or clarithromycin) that cannot be stopped at least 4 weeks before screening
• You are taking certain other medications that also affect how drugs are processed (such as rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort, or efavirenz) that cannot be stopped at least 4 weeks before screening
• You have received chemotherapy treatment within the last 12 months
• You regularly eat grapefruit and are unwilling or unable to stop during the study
• The trial team believes you would not be able to complete the study as required
• You are not able to read, write, or understand Danish

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