Study participants
bladder carcinoma, haematuria, angina, diabetes
DIABETIC KETOACIDOSIS, MYOCARDIAL INFARCTION, STROKE, LIVER FAILURE, BLADDER CARCINOMA, LIVER DISEASE, HAEMATURIA, PANCREATITIS, HEART FAILURE, TYPE 2 DIABETES, DIABETES
Participants were adults aged ≥30 and ≤80 years, with a clinical diagnosis of type 2 diabetes for at least 12 months and treated with either metformin alone or two classes of oral glucose-lowering therapy (given either as separate or combined medications), that do not include a DPP4-inhibitor, a SGLT2-inhibitor or a thiazolidinedione. This was likely to be metformin and sulphonylurea but included prandial glucose regulators nateglinide or repaglinide. No change of diabetes treatment (new therapy or dose change) was permitted in the previous 3 months. Participants had an HbA1c > 58mmol/mol (7.5%) and ≤110mmol/mol (12.2%) and eGFR ≥ 60mls/min/1.73mPatients were excluded if screening blood tests identified alanine transaminase (ALT) >2.5 x upper limit of the assay normal range (ULN) or known liver disease, specifically bilirubin >30 μmol/L associated with other evidence of liver failure, an HbA1c ≤58mmol/mol (7.5%) or >110mmol/mol (12.2%), or eGFR <60mls/min/1.73Patients could not be recruited if undergoing current/ ongoing investigation for macroscopic haematuria, had recent (within 3 months) or planned significant surgery, or had experienced an acute cardiovascular episode (angina, myocardial infarction, stroke, transient ischemic episode) within the previous 3 months. Also excluded were patients with any history of heart failure, bladder carcinoma, diabetic ketoacidosis or pancreatitis. Patients were not recruited if pregnant, breastfeeding or planning a pregnancy over the study period, and concurrent participation on another clinical trial of investigational medicinal product (CTIMP) where the investigational medicinal product (IMP) was currently being taken, without sufficient washout period (5x half-life of IMP/potential-IMP) was also not permitted.Participants were identified in primary care and from existing research cohorts. People with type 2 diabetes were eligible if aged 30-80 years on stable doses of metformin alone, or metformin plus a sulfonylurea, with HbA1c >58mmol/mol (>7.5%) and <110mmol/mol (≥12.2%). 