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

NCT01575301 | Completed

• 1 other identifier: 2011DIRECT01 (GLP)
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes

Keywords

GLP-1R agonist; biomarker

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Exenatide, Liraglutide DRUG

Dosage, frequency and duration not specified by protocol

Also known as: Byetta, Victoza

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type 1 diabetes
• HbA1c \<7.5% (58 mmol/mol)
• HbA1c ≥ 12% (108 mmol/mol)
• Pregnancy or lactation
• Inability to consent
• Participating in a CTIMP during the study period and within 30 days prior to study start.

Sponsors & Collaborators

• University of Dundee: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (4)

Ninewells Hospital

Dundee, Angus, DD1 9SY, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Oxford Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Newcastle Hospitals NHS Trust

Newcastle, Teeside, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exenatide; Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ewan Pearson

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 11, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: December 11, 2015
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

GB (4)