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Completed

NCT Number: NCT01575301

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital, Dundee, Angus, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist
  • Either:
  • On any combination of oral hypoglycaemic agents
  • 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.

Treatment and study plan

Exenatide, Liraglutide

Drug

Dosage, frequency and duration not specified by protocol

Other names: Byetta, Victoza

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

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

Registry information

Acronym: DIRECTGLP

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2012
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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