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

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ClinicalTrials.gov Identifier: NCT01575301
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Royal Devon and Exeter NHS Foundation Trust
Information provided by (Responsible Party):
Ewan Pearson, University of Dundee

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Exenatide, Liraglutide Not Applicable

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  (Clinical Trial)
Actual Enrollment : 411 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
Study Start Date : March 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 11, 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Exenatide, Liraglutide
    Dosage, frequency and duration not specified by protocol
    Other Names:
    • Byetta
    • Victoza


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575301


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

Responsible Party: Ewan Pearson, Chief Investigator, University of Dundee
ClinicalTrials.gov Identifier: NCT01575301     History of Changes
Other Study ID Numbers: 2011DIRECT01 (GLP)
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Ewan Pearson, University of Dundee:
GLP-1R agonist
biomarker

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists