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

Diabetes Clinical Trial

— DIRECTGLP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575301
• Other study ID #: 2011DIRECT01 (GLP)
• Status: Completed
• Phase: N/A
• First received: March 29, 2012
• Last updated: April 9, 2018
• Start date: March 2011
• Est. completion date: December 11, 2015

Study information

• Verified date: April 2018
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: December 11, 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• Exenatide, Liraglutide
Dosage, frequency and duration not specified by protocol

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital	Dundee	Angus
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon
United Kingdom	Newcastle Hospitals NHS Trust	Newcastle	Teeside
United Kingdom	Oxford Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Dundee	Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c between baseline and 6 months	The primary outcome is the change in HbA1c (absolute difference between the baseline and 6 month measure) in mmol/mol	6 months