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:

• People who are able to understand and willingly sign a written consent form
• People aged 18 to 74 years old
• People who have been diagnosed with type 2 diabetes
• People who have been taking one specific type of diabetes medication (called an SGLT2 inhibitor — one of: dapagliflozin 10mg, canagliflozin 100mg, empagliflozin 10mg, ertugliflozin 5mg, or henagliflozin 10mg) on its own for at least 8 weeks
• People who have been taking metformin at a dose of 500–1000mg per day for at least 8 weeks, with no dose changes during the screening period
• People whose HbA1c blood sugar level (a measure of average blood sugar over recent months) is between 7.5% and 9.5%
• People whose fasting blood sugar level is below 15 mmol/L before joining the trial
• People whose body mass index (BMI, a measure of body weight relative to height) is 40 or below before joining the trial
• People whose urine ketone test result is negative before joining the trial
• People whose kidney function score (eGFR) is 60 ml/min/1.73m² or higher before joining the trial
• People who are willing to keep their diet and exercise habits the same throughout the trial, and who are able to use a home blood sugar monitor and keep records of their readings

Who may not be able to join:

• People who have type 1 diabetes
• People who have a form of diabetes caused by another medical condition (secondary diabetes)
• People who are waiting for, or have already had, a pancreas or insulin-cell transplant
• People with a history of pancreas inflammation (pancreatitis) or pancreas removal surgery
• People who have had a serious diabetes complication called diabetic ketoacidosis or a hyperosmolar coma
• People with moderate or severe liver problems, including those whose liver enzyme levels (ALT, AST, or alkaline phosphatase) are more than three times the normal upper limit during screening
• People who have had a heart attack, unstable chest pain, stroke, or mini-stroke (TIA) in the past 3 months
• People with poorly controlled high blood pressure (systolic pressure at or above 160 mmHg, or diastolic pressure at or above 90 mmHg)
• People whose haemoglobin (a measure of red blood cells) is below 10 g/L or 100 mg/dL
• People who have had more than two urinary or genital infections in the past 3 months
• People who have had weight-loss (bariatric) surgery or other gut surgeries that affect nutrient absorption in the past 2 years
• People who have taken weight-loss medication in the past 3 months, or who have had any treatment (including surgery or extreme dieting) that caused their weight to be unstable at the time of screening
• People with a history of cancer (other than a specific minor skin cancer called basal cell carcinoma) or cancer treatment in the past 5 years
• People who are HIV positive
• People with serious problems with blood flow to their limbs (severe peripheral vascular disease)
• People with blood cancers or any condition that causes the breakdown of red blood cells (such as malaria, babesiosis, or haemolytic anaemia)
• People with immune system diseases, or people currently taking steroid medications that affect the whole body
• People whose thyroid medication dose has changed in the past 6 weeks, or who have any other uncontrolled hormone or metabolic condition besides type 2 diabetes
• People with alcohol or drug misuse in the past 3 months that could affect their ability to follow the trial requirements, or anyone with a long-term illness that the trial doctor believes may affect their ability to participate properly
• People with a known allergy to any ingredient in the study medication or to similar medications
• Women who are pregnant, planning to become pregnant during the study, or breastfeeding; women who are unwilling to use reliable contraception (such as condoms, spermicide, or an intrauterine device) from the time of signing consent until 28 days after the last dose; women planning to use progesterone-based contraception during this period; and men who are planning to father a child during the study
• People who have taken part in another clinical trial in the past 30 days
• Anyone the trial doctor considers unsuitable for the study for any other reason

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