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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-12-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Exenatide, Liraglutide

Dosage, frequency and duration not specified by protocol

Intervention Type DRUG

Other Intervention Names

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Byetta Victoza

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No