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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01575301

Acronym

DIRECTGLP

Enrollment

411

Registered

2012-04-11

Start date

2011-03-31

Completion date

2015-12-11

Last updated

2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

GLP-1R agonist, biomarker

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.

Interventions

DRUGExenatide, Liraglutide

Dosage, frequency and duration not specified by protocol

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026