TriMaster: Study of a DPP4 Inhibitor, SGLT2 Inhibitor and Thiazolidinedione as Third Line Therapy in Patients With Type 2 Diabetes.

Sponsor
Royal Devon and Exeter NHS Foundation Trust
Study ID
NCT02653209
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sitagliptin - DPP4i — DRUG
    DPP4 inhibitor 100mg supplied as over-encapsulated hard capsule shell to be taken orally, once a day for 16 weeks in addition to existing prescribed oral diabetes therapy.
  • Canagliflozin - SGLT2i — DRUG
    SGLT2 inhibitor 100mg supplied as over-encapsulated hard capsule shell to be taken orally, once a day for 16 weeks in addition to existing prescribed oral diabetes therapy.
  • Pioglitazone - TZD — DRUG
    Thiazolidinedione 30mg supplied as over-encapsulated hard capsule shell to be taken orally, once a day for 16 weeks in addition to existing prescribed oral diabetes therapy.

Study Details

The aim of this project is to identify subgroups of patients with type 2 diabetes that respond well or poorly to particular drugs based on particular clinical characteristics such as their weight or kidney function, to enable better targeting of treatment for a particular individual. This 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.

Key Dates

Start date
Nov 1, 2016
Status verified
Mar 2021
Primary completion
Jan 31, 2021
Completion
Jan 31, 2021

Study Design

Enrollment
525 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sitagliptin - DPP4i
  • Experimental: Canagliflozin - SGLT2i
  • Experimental: Pioglitazone - TZD

Primary Outcome Measure

On treatment HbA1c in obese patients (BMI >30kgm-2), compared to non-obese patients [ Time Frame: 16 weeks ]

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