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:

For healthy volunteers (Part A):

• People who are in generally good health, based on their medical history and a physical check-up.

For people with Type 1 Diabetes (Parts B and C):

• People who have had Type 1 Diabetes for at least 2 years, with low levels of a protein called C-peptide (a marker of the body's own insulin production), measured by a blood test.
• People whose long-term blood sugar control (HbA1c) is between 6.0% and 8.5%.
• People who use an insulin pump with a daily background (basal) insulin dose between 15 and 45 units.

For people with Type 1 Diabetes (Part D):

• People who have had Type 1 Diabetes for at least 1 year, with low C-peptide levels on a blood test.
• People whose HbA1c is between 6.0% and 8.5%.
• People who use an insulin pump with a daily background (basal) insulin dose between 15 and 45 units.
• People who use multiple daily insulin injections (specifically glargine or degludec insulin) with a total daily insulin dose within a certain range based on body weight.
• People who are aware of their low blood sugar (hypoglycaemia) episodes — meaning they can feel the warning signs.
• People whose background (basal) insulin makes up between 30% and 70% of their total daily insulin dose.
• People who are physically able to complete an exercise test as part of the study.

For all parts of the trial:

• People with normal blood pressure, heart rate, and acceptable routine blood test results.
• People with a body mass index (BMI) between 18.0 and 35.0 (a standard measure of body weight relative to height).
• People with veins suitable for blood draws.
• Male participants, or female participants who are not able to become pregnant.

Who may not be able to join:

For people with Type 1 Diabetes (Parts B, C, and D):

• People who have visited an emergency room or been hospitalised more than once in the past 6 months due to dangerously high blood sugar or diabetic ketoacidosis.
• People who have had a severe low blood sugar episode requiring help from another person, or who are unable to feel the warning signs of low blood sugar, within the past 6 months.

For people with Type 1 Diabetes (Parts B and C):

• People who have taken certain diabetes or blood sugar medications (including GLP-1 receptor agonists, DPP-4 inhibitors, GIP agonists, Metformin, or SGLT2 inhibitors) within the past 3 months.
• People who have used steroid medication taken by mouth or inhaled (not including creams, joint injections, or eye drops) for more than 14 days in a row within the 4 weeks before screening.

For people with Type 1 Diabetes (Part D):

• People who have taken certain diabetes medications (including DPP-4 inhibitors, GLP-1 receptor agonists, GIP/GLP-1 combined agonists, Metformin, Pramlintide, SGLT2 inhibitors, or NPH insulin) within the past 3 months.

For all parts of the trial:

• People who have had a heart attack, severe heart failure, or a stroke.
• People who have a condition where the stomach empties too slowly (gastroparesis), or who have had weight-loss (bariatric) surgery.
• People who have had a kidney transplant, are currently on kidney dialysis, or have certain blood test results indicating reduced kidney function.
• People with active or long-term liver disease (other than non-alcoholic fatty liver disease, which does not automatically exclude participation), or certain abnormal liver-related blood test results above set limits.

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