Phase 4 Type 1 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 are between 18 and 70 years old (inclusive)
• It has been more than one year since your spinal cord injury
• Your spinal cord injury is at a level between C2 and L2, with any level of impairment on the standard injury scale (A, B, C, or D)
• You are willing and able to sign a consent form before any study activities begin
• You have been diagnosed with Type 2 diabetes, and your blood sugar is managed only with diet and the medication metformin, with no major dose changes in the last three months
• Your HbA1c (a measure of average blood sugar over time) is between 6.0% and 9.0% at the screening visit
• Your BMI (body mass index) is above 22 kg/m²
• If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study and are not currently breastfeeding
• If you are a woman who could become pregnant and are sexually active with a male partner who has not been sterilised, you must use at least one reliable form of contraception throughout the study (note: rhythm method, periodic abstinence, and withdrawal are not accepted as suitable methods)

Who may not be able to join:

• You have any existing health condition that, in the opinion of the study doctor, could interfere with the study, put you at risk, or affect the results
• You have taken part in another clinical trial in the last 30 days (or longer, depending on the drug used)
• You are currently taking mirabegron or any other medications that affect blood sugar levels
• You have taken steroid medications at any point in the past year
• You have significant anaemia (low red blood cell levels, specifically haemoglobin below 11g/dL)
• You have a history of a blockage in your stomach outlet or long-term (chronic) diarrhoea
• You have a chronic neurological condition other than your spinal cord injury (for example, multiple sclerosis)
• You have taken certain weight-loss or appetite-control medications within the past year, or certain diabetes medications (such as pioglitazone, SGLT2 inhibitors, DPPIV inhibitors, or GLP-1 medications) within the past 60 days
• You have a serious allergy or sensitivity to any of the study treatments or to paracetamol (acetaminophen)
• You have symptoms of severely uncontrolled blood sugar (such as extreme thirst, frequent urination, or unexplained weight loss), a history of Type 1 diabetes or diabetic ketoacidosis, or have used daily insulin injections within the past 90 days
• You have significant inflammatory bowel disease or have had major surgery on your upper digestive tract (note: prior weight-loss/bariatric surgery is not automatically excluded — confirm with trial site)
• You have a history of acute or chronic pancreatitis (inflammation of the pancreas)
• You have significant liver disease (certain liver conditions may still be acceptable — confirm with trial site), or your liver function blood test results are significantly above the normal range at screening
• Your kidney function is reduced below a certain level (eGFR below 45 mL/minute/1.73m²) at screening
• You have had a heart attack, unstable chest pain, mini-stroke, or stroke in the last 3 months, or have had certain heart procedures in the last 6 months
• You have severe heart failure (classified as New York Heart Association Class III or IV)
• You have elevated calcitonin levels in your blood, or a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related condition (multiple endocrine neoplasia)
• You have had cancer in the last 5 years (some minor skin cancers or cervical cancer in situ may be exceptions — confirm with trial site)
• You have a history of HIV or another condition that significantly weakens your immune system, or you have had an organ transplant
• You have a history of substance dependence, alcohol abuse, or regularly drink excessive amounts of alcohol
• You are currently following a ketogenic (very low carbohydrate) diet

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