Providing information for patients and professionals on research and clinical care in genetic types of diabetes.

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

ISRCTN 12039221 

ClinicalTrials.gov NCT02653209

In type 2 diabetes, it is common for additional treatments to be added over time to maintain, or lower, blood sugar levels. Responses to this change of treatment can vary between individuals, but little is known about why this happens. If it was possible to predict which medicine is likely to work for a person, the most effective treatment could be chosen from the start, avoiding ineffective medicines and unnecessary side effects.

The current guidelines for treatment of patients with Type 2 diabetes list a large number of drugs without giving clear guidance on which patients should have which drugs. This makes it difficult for patients and their health care professionals to know which drugs are likely to suit them best.

Aim

This study is looking at three standard diabetes treatments which can be added when two existing medicines stop maintaining good blood sugar levels. The study will compare how patients with different blood sugar levels, weight and kidney function respond, and which treatment each patient prefers.

The aim is to identify subgroups of patients with type 2 diabetes that respond well or poorly to particular drugs based on these clinical characteristics, to enable better targeting of treatment for a particular individual.

Study Overview

TriMaster will run from Autumn 2016 to July 2019 at 20 sites across the UK. The study will test 2 hypotheses of drug response supported by routine clinical and trial data. 600 patients with type 2 diabetes who have suboptimal glycaemic control on dual oral therapy will be recruited to a randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione. Each patient will take each study drug in addition to their existing treatment for four months at a time. At the end of each treatment the patient's glucose control will be measured and information about their experience of the drug will be collected. 

Who Can Take Part?

Adults aged between 30 and 80 who have Type 2 Diabetes and are currently taking two oral diabetes medications but whose blood sugar levels mean they need an additional (third) medication. 

Where is the study run from?
Royal Devon and Exeter Hospital (lead centre) and 19 other hospitals in England, Scotland and Wales (UK)

Contacts:

Chief Investigator: Andrew Hattersley

Trial Manager: Catherine Angwin c.angwin@exeter.ac.uk  01392 408185