TriMaster - a research study to help improve treatment of type 2 diabetes, by learning how individuals respond to different blood sugar-lowering drugs

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN12039221
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-30
• Study Completion: 2021-12-14
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified