Phase 4 Type 2 Diabetes Trial, Recruiting

Written by an AI model from the 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 between 18 and 80 years of age.
• People who have had a type 2 diabetes diagnosis for at least 3 years.
• People whose kidneys are functioning within a specific moderate range, as measured by a blood test called eGFR (between 45 and 90 ml/min/1.73m²) — confirm with trial site.
• People whose urine protein levels (albumin-to-creatinine ratio) are below 3000 mg/g at the screening stage.
• People who are willing to take part after being fully informed about the study.
• People already taking a blood pressure/kidney-protective medication called a RAAS inhibitor, provided they have been on the highest tolerated dose for at least 3 months before the study starts.
• People already taking a diabetes medication called a GLP-1 receptor agonist, provided they have been on it for at least 3 months before the study starts.
• People who meet the current medical guidelines that allow a doctor to prescribe SGLT2 inhibitor medications under FDA-approved standards.

Who may not be able to join:

• People with significant liver problems, such as cirrhosis, hepatitis, portal hypertension, or elevated bilirubin levels.
• People with active or uncontrolled heart disease, symptomatic circulation problems in the legs, uncontrolled lung conditions, kidney or urinary tract disorders, significant digestive problems causing weight loss, or very low blood count (low hematocrit).
• People who are currently taking, or have previously taken, SGLT2 inhibitor medications.
• People with severely uncontrolled or a specific dangerous type of high blood pressure (systolic at or above 150 mmHg, or diastolic at or above 90 mmHg).
• People with blood in their urine where the cause has not been identified and explained.
• People with ongoing serious conditions such as lupus, cancer, amyloidosis, or chronic infection that could affect kidney function measurements or life expectancy during the study.
• People currently taking steroids, immune-suppressing medications, or other experimental drugs not related to this trial.
• People who are pregnant, planning a pregnancy in the next three years, or not willing to use effective contraception throughout the study. Women of childbearing potential must have a negative pregnancy test before starting and every two months during the study.
• People with a known allergy or sensitivity to canagliflozin (the study drug) or iodine.
• People with bleeding disorders, or who take blood-thinning or anti-clotting medications that cannot be safely paused, as kidney biopsies cannot be performed safely in these cases.
• People with a body mass index (BMI) of 45 or above (very high weight relative to height), as this makes kidney biopsies more technically difficult.
• People with a known allergy to iodine-containing contrast dye or shellfish.
• People whose kidney disease is not caused by diabetes.
• People with a history of bone fractures related to osteoporosis.
• People with a history of amputation of a lower limb, for any reason.
• People whose circumstances may make it difficult to give informed consent or follow the study requirements.
• People with only one kidney.
• People whose kidneys measure below 9 cm on ultrasound, or where there is more than a 2 cm size difference between the left and right kidney.
• People currently taking certain medications including UGT enzyme inducers, lithium, or digoxin.
• People with certain blood test results outside acceptable ranges, including high blood urea nitrogen, abnormal clotting results (INR or PTT), low platelet count, or low haemoglobin — these may be reconsidered if results come back within range (confirm with trial site).
• People with a blockage or fluid build-up in the kidneys (hydronephrosis) or other significant findings on kidney ultrasound, such as serious kidney stones — these may be reconsidered once addressed (confirm with trial site).

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