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

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT01575301
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-11
• Primary Completion: 2015-07
• Study Completion: 2015-12-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in HbA1c between baseline and 6 months	6 months	The primary outcome is the change in HbA1c (absolute difference between the baseline and 6 month measure) in mmol/mol

Trial Locations

Locations (4)

Ninewells Hospital; 🇬🇧 Dundee, Angus, United Kingdom

Oxford Hospitals NHS Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom

Royal Devon and Exeter NHS Foundation Trust; 🇬🇧 Exeter, Devon, United Kingdom

Newcastle Hospitals NHS Trust; 🇬🇧 Newcastle, Teeside, United Kingdom