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

University of Dundee

Status

Completed

Conditions

Diabetes

Treatments

Drug: Exenatide, Liraglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT01575301

2011DIRECT01 (GLP)

Details and patient eligibility

About

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.

Full 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.

Enrollment

411 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.