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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

Tracking Information
First Submitted Date  ICMJE March 29, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date April 11, 2018
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
Official Title  ICMJE DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes
Intervention  ICMJE Drug: Exenatide, Liraglutide
Dosage, frequency and duration not specified by protocol
Other Names:
  • Byetta
  • Victoza
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2018)
411
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
800
Actual Study Completion Date  ICMJE December 11, 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575301
Other Study ID Numbers  ICMJE 2011DIRECT01 (GLP)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ewan Pearson, University of Dundee
Study Sponsor  ICMJE University of Dundee
Collaborators  ICMJE
  • Newcastle-upon-Tyne Hospitals NHS Trust
  • Oxford University Hospitals NHS Trust
  • Royal Devon and Exeter NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Ewan Pearson University of Dundee
PRS Account University of Dundee
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP