DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists (DIRECTGLP)

April 9, 2018 updated by: Ewan Pearson, University of Dundee
The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To develop a cohort of patients treated with GLP-1 R Agonists who are phenotyped at baseline and at 6 month follow up to determine clinical, imaging and other biomarker predictors of glycaemic response to GLP-1R Agonists. The hypothesis is that one, or a combination, of these biomarkers is associated with glycaemic response to GLP-1R Agonists. The primary outcome is therefore HbA1c reduction after 6 months of GLP-1R A treatment.

This is a cohort study of 800 patients being treated with either exenatide or liraglutide for 6 months, and carried out in 4 UK centres.

Study Type

Interventional

Enrollment (Actual)

411

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Ninewells Hospital
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon and Exeter NHS Foundation Trust
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Oxford Hospitals NHS Trust
    • Teeside
      • Newcastle, Teeside, United Kingdom, NE1 4LP
        • Newcastle Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist

  • Either:

    1. On any combination of oral hypoglycaemic agents
    2. On Insulin (+/- oral hypoglycaemic agents)
  • HbA1c ≥7.5% (58mmol/mol) and HbA1c < 12% (108mmol/mol)
  • White European
  • Age ≥ 18 and < 80

Exclusion Criteria:

  • Type 1 diabetes
  • HbA1c <7.5% (58 mmol/mol)
  • HbA1c ≥ 12% (108 mmol/mol)
  • Pregnancy or lactation
  • Any other significant medical reason for exclusion as determined by the investigator
  • Inability to consent
  • Participating in a CTIMP during the study period and within 30 days prior to study start.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c between baseline and 6 months
Time Frame: 6 months
The primary outcome is the change in HbA1c (absolute difference between the baseline and 6 month measure) in mmol/mol
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Royal Devon and Exeter NHS Foundation Trust

Investigators

  • Principal Investigator: Ewan Pearson, University of Dundee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 11, 2015

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011DIRECT01 (GLP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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