Phase 1 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:

• Adults aged 18 to 65 years old, of any race or gender
• People with a body mass index (a measure of body weight relative to height) between 18 and 38
• Women who are not pregnant or breastfeeding, and all participants who agree to use contraception as specified by the trial
• People who have been diagnosed with Type 2 diabetes, either managed through diet and exercise alone, or who have been on a stable dose of metformin (up to 2000 mg) for at least one month, and/or have been on other stable diabetes medications for at least 90 days
• People who are generally in good health aside from their Type 2 diabetes, as assessed by the trial doctor through medical history, heart tests, physical exams, and lab results
• People whose blood pressure or cholesterol medications have been at a stable dose for at least 30 days before the trial starts
• People whose HbA1c (a measure of average blood sugar over time) is between 7.0% and 10.5%
• People whose fasting blood sugar level is between 126 and 240 mg/dL
• People who are willing and able to understand and sign a consent form and follow the trial's rules

Who may not be able to join:

• People with Type 1 diabetes, a rare genetic form of diabetes, or diabetes caused by another condition such as pancreas damage, acromegaly, or Cushing's syndrome
• People who have diabetes-related nerve damage, eye damage, or kidney damage
• People who have had serious diabetic complications such as diabetic ketoacidosis, a dangerous blood sugar crisis, or a related condition in the 6 months before the trial, or who have ongoing chronic metabolic acidosis
• People who have had a severe low blood sugar episode requiring help from another person in the past 3 months, two or more moderate low blood sugar episodes in the past 3 months, or a serious low blood sugar event in the past 6 months
• People who cannot feel the warning signs of low blood sugar
• People with a significant liver disease such as hepatitis or cirrhosis in the past year
• People with significant kidney disease (mild to moderate chronic kidney disease may be permitted — confirm with trial site)
• People with significant heart or cardiovascular disease such as coronary artery disease, irregular heartbeat, or heart failure in the past year (managed high blood pressure with readings below certain levels may be permitted — confirm with trial site)
• People with significant brain or mental health conditions such as stroke, seizures, depression, or behavioural disturbances in the past year
• People with serious stomach or digestive problems, such as severe diabetic gastroparesis, gastric outlet obstruction, or a history of gastric bypass surgery
• People with significant or unstable conditions affecting the liver, kidneys, blood, lungs, heart, gut, nerves, hormonal system, or mental health, as determined by the trial doctor
• People with a known or active cancer, except for certain common skin cancers (basal cell carcinoma and cutaneous squamous cell carcinoma)
• People who have been hospitalised or had major surgery in the 90 days before the trial
• People with a significant history of serious allergies or intolerances to medications, foods, or other substances, as determined by the trial doctor
• People whose fasting C-peptide level (a marker of insulin production) is below a specified threshold
• People with certain abnormal liver enzyme or bilirubin results on blood tests
• People with very high triglyceride (blood fat) levels above 500 mg/dL
• People with significantly reduced kidney filtering function below a specified level
• People with low haemoglobin (a measure of red blood cells) below specified levels for their gender
• People with a prolonged heart electrical interval (QT interval) on an ECG above a specified measurement
• People who test positive for hepatitis B, hepatitis C, or HIV
• People who test positive on a pregnancy test
• People currently using certain diabetes medications including insulin, sulfonylureas, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitors, or glinides
• People who have recently used certain medications that affect how the body processes drugs (specific enzyme inducers or inhibitors), within specified timeframes before the trial
• People who have taken part in another clinical trial involving an experimental drug in the past 30 days
• People who test positive for alcohol or illegal drugs at screening or check-in
• People with a current drug or alcohol misuse problem
• People who have consumed alcohol, caffeine, grapefruit, or Seville oranges within specified timeframes before the trial begins
• People who have used tobacco or nicotine products in the month before the trial
• People who have donated or received more than approximately 450 mL of blood in the 3 months before the trial
• People with poor vein access that would make blood draws difficult
• People whom the trial doctor considers should not participate, for any reason

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