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

Sponsor

University of Dundee (Other)

Overall Status

Completed

CT.gov ID

NCT01575301

Collaborator

Newcastle-upon-Tyne Hospitals NHS Trust (Other), Oxford University Hospitals NHS Trust (Other), Royal Devon and Exeter NHS Foundation Trust (Other)

411

Enrollment

Locations

57.4

Duration (Months)

102.8

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Exenatide, Liraglutide	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

411 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Dec 11, 2015

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ninewells Hospital	Dundee	Angus	United Kingdom	DD1 9SY
2	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon	United Kingdom	EX2 5DW
3	Oxford Hospitals NHS Trust	Oxford	Oxfordshire	United Kingdom	OX3 7LJ
4	Newcastle Hospitals NHS Trust	Newcastle	Teeside	United Kingdom	NE1 4LP