DiabetesDIRECTGLPNCT01575301
DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
A study testing Exenatide, Liraglutide in people with Diabetes, run by University of Dundee at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Exenatide, Liraglutide
- How many people
- 411 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Mar 2011to 11 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Ninewells Hospital
Dundee, Angus, DD1 9SY
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
Newcastle Hospitals NHS Trust
Newcastle, Teeside, NE1 4LP
Oxford Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LJ
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Exenatide, Liraglutide
- Keywords
- GLP-1R agonist, biomarker
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide, LiraglutideDrug
Also called Byetta, Victoza
Dosage, frequency and duration not specified by protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completion11 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Principal investigator, Ewan Pearson, University of Dundee
- Investigators
- Ewan Pearson, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575301
- Sponsor's protocol ID
- 2011DIRECT01 (GLP)
- Acronym
- DIRECTGLP
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2012
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
- ClinicalTrials.gov ID
- NCT01575301
- Acronym / sponsor ID
- DIRECTGLP / 2011DIRECT01 (GLP)
- Conditions
- Diabetes
- Keywords
- GLP-1R agonist, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Royal Devon and Exeter NHS Foundation Trust
- Study start
- Mar 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- 11 Dec 2015 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist
- Either:
- HbA1c ≥7.5% (58mmol/mol) and HbA1c < 12% (108mmol/mol)
- White European
- Age ≥ 18 and < 80
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide, LiraglutideAlso: Byetta, VictozaDosage, frequency and duration not specified by protocol | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewan Pearson principal investigator
University of Dundee
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide, Liraglutide in people with Diabetes, run by University of Dundee at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c between baseline and 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.