DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists (DIRECTGLP)
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ClinicalTrials.gov Identifier: NCT01575301 |
Recruitment Status :
Completed
First Posted : April 11, 2012
Last Update Posted : April 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes | Drug: Exenatide, Liraglutide | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
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 : | March 2011 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | December 11, 2015 |

- Drug: Exenatide, Liraglutide
Dosage, frequency and duration not specified by protocolOther Names:
- Byetta
- Victoza
- Change in HbA1c between baseline and 6 months [ Time Frame: 6 months ]The primary outcome is the change in HbA1c (absolute difference between the baseline and 6 month measure) in mmol/mol

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575301
United Kingdom | |
Ninewells Hospital | |
Dundee, Angus, United Kingdom, DD1 9SY | |
Royal Devon and Exeter NHS Foundation Trust | |
Exeter, Devon, United Kingdom, EX2 5DW | |
Oxford Hospitals NHS Trust | |
Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
Newcastle Hospitals NHS Trust | |
Newcastle, Teeside, United Kingdom, NE1 4LP |
Principal Investigator: | Ewan Pearson | University of Dundee |
Responsible Party: | Ewan Pearson, Chief Investigator, University of Dundee |
ClinicalTrials.gov Identifier: | NCT01575301 |
Other Study ID Numbers: |
2011DIRECT01 (GLP) |
First Posted: | April 11, 2012 Key Record Dates |
Last Update Posted: | April 11, 2018 |
Last Verified: | April 2018 |
GLP-1R agonist biomarker |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Obesity Agents |