TriMaster: Randomised Double-Blind Crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as third line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on dual therapy with metformin and a sulphonylurea

Royal Devon and Exeter NHS Foundation Trust0 个研究点目标入组 525 人开始时间: 2016年11月30日最近更新: 2023年1月9日

试验速览

2020 Protocol article in https://doi.org/10.1136/bmjopen-2020-042784 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36477734/ prespecified secondary endpoint data (added 12/12/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36477733/ primary endpoint results (added 12/12/2022)

•1. Clinical diagnosis of Type 2 diabetes
•2. Age =30 and =80
•3. Currently treated with 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 is likely to be metformin and sulphonylurea but may include prandial glucose regulators nateglinide or repaglinide.
•4. No change in diabetes treatment (new treatments or dose change) within previous 3 months
•5. HbA1c > 58mmol/mol (7.5%) – confirmed at screening visit
•6. eGFR = 60mls/min/1.73m² - confirmed at screening visit
•7. Able and willing to give informed consent

•1. Changes in glucose-lowering therapy or dose within last 3 months
•2. HbA1c = 58mmol/mol (7.5%)
•3. eGFR 2.5 x upper limit of the assay normal range or known liver disease, specifically >30 µmol/L that is associated with other evidence of liver failure.
•4. Currently treated with corticosteroids
•5. Active infection (any infection requiring antibiotics at present)
•6. Active foot ulcer
•7. Recent (within 3 months) significant surgery or planned surgery (excluding minor procedures)
•8. Acute cardiovascular episode (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
•9. History of heart failure or current use of loop diuretic therapy (Furosemide or Bumetanide)
•10. History of bladder carcinoma or current/ongoing investigation for macroscopic haematuria
•11. History of Diabetic Ketoacidosis or pancreatitis
•12. Pregnant, breastfeeding or planning a pregnancy over the study period
•13. Concurrent Participation on another Clinical Trial of an Investigational Medicinal Product
•14. Unable or unwilling to give informed consent

发起方

Royal Devon and Exeter NHS Foundation Trust