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

NCT02653209 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2021-04-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sitagliptin - DPP4i

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.

DRUG

Canagliflozin - SGLT2i

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.

DRUG

Pioglitazone - TZD

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.

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER

  • NHS Tayside

    collaborator OTHER_GOV

  • University of Dundee

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew Hattersley · University of Exeter / Royal Devon & Exeter NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653209 on ClinicalTrials.gov