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:

• People aged 18 to 75 years old at the time of signing the consent form
• People who have been clinically diagnosed with both Type 2 Diabetes and Chronic Kidney Disease (a condition where the kidneys do not filter blood as well as they should) before the screening visit
• People whose urine tests have shown a high level of a protein called albumin (a ratio above 200 mg/g) on at least two separate occasions before screening
• People whose kidney disease has been diagnosed for at least 3 months and is at a mild-to-moderate stage, with kidney filtering function within a specific range at screening (confirm with trial site for exact values)
• People whose Type 2 Diabetes diagnosis has been confirmed, and whose diabetes medication dose (if any) has been stable for at least 3 months, with a blood sugar control reading (HbA1c) of 9% or below at screening
• People who have been on a stable dose of a blood pressure or kidney-protecting medication (such as certain blood pressure tablets or diabetes medications known to protect the kidneys) for at least 4 weeks before screening
• People with a body weight in a healthy range (BMI between 18.5 and 40 kg/m²) that has been stable, with no more than 10% weight loss in the 3 months before the baseline visit and no major lifestyle changes in that time
• Women who could become pregnant, and men who are sexually active with partners who could become pregnant, who agree to use reliable contraception or abstain from sex during the study and for 30 days after the last dose
• People who are able to understand the study, sign the consent form, and follow the study plan

Who may not be able to join:

• People with kidney diseases that are inherited or present from birth, such as polycystic kidney disease, autoimmune kidney disease, or structural problems with the urinary tract
• People who are currently on, or have been on within the past 90 days, regular kidney dialysis (either hemodialysis or peritoneal dialysis)
• People with confirmed severe liver scarring (cirrhosis, Fibrosis Stage 4)
• People with a history of serious liver complications such as fluid build-up in the abdomen, confusion caused by liver failure, or bleeding from swollen veins in the food pipe
• People with certain active liver diseases at screening, including autoimmune hepatitis, primary biliary cholangitis, alcohol-related liver disease, Wilson's disease, or liver damage caused by medications
• People who have had gastric bypass surgery
• People with a history of stomach or intestinal ulcers in the 12 months before joining the trial
• People with a history of active inflammatory bowel disease in the 12 months before joining the trial
• People with severe gut conditions at screening that affect how medications are absorbed, including conditions that cause frequent diarrhoea such as irritable bowel syndrome, ulcerative colitis, or Crohn's disease
• People who have had a heart attack, stroke, uncontrolled irregular heartbeat, unstable chest pain, or heart bypass or stent surgery within 6 months before screening
• People with a current or past history of the most severe level of heart failure (Class IV)
• People who have a planned procedure to open blocked arteries in the heart, neck, or legs
• People with high blood pressure that remains uncontrolled despite taking blood pressure medication, above a specific level (confirm with trial site)
• People with blood disorders or conditions that cause red blood cells to break down or be unstable, including certain enzyme deficiencies, anaemia of various types, chronic malaria, or removal of the spleen
• People with a current or recent history (within the past 2 years) of cancer, except for certain treated skin cancers
• People who are currently receiving, or who plan to receive, radiotherapy, strong chemotherapy, or immune-modifying treatments
• People with significantly abnormal blood test results or heart tracing (ECG) results at screening, including low platelet counts, abnormal clotting levels, abnormal liver enzyme levels, or an abnormal heart rhythm reading (confirm with trial site for specific values)
• People who have had a serious infection requiring hospital-level antibiotic or antifungal treatment within 30 days before or at screening
• People who test positive at screening for HIV, syphilis, active Hepatitis B, or active Hepatitis C
• People who have had major surgery within 30 days before screening
• People who have received a solid organ transplant or are on a waiting list for one
• People who have donated blood or lost 400 mL or more of blood within 3 months before screening, or who are expected to need a blood transfusion within 12 weeks of joining
• People who have been exposed to the study drugs (Ursodeoxycholic Acid or Berberine) within 3 months before screening, or who have a known allergy to either
• People with a history or confirmed diagnosis of Type 1 Diabetes
• Women who are pregnant, breastfeeding, planning a pregnancy, or of childbearing potential and not using reliable contraception
• People who have taken part in another clinical trial within 30 days before screening
• People with any other condition that the trial doctor believes could affect their safety or ability to follow the study plan

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