- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575301
DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists (DIRECTGLP)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Angus
-
Dundee, Angus, United Kingdom, DD1 9SY
- Ninewells Hospital
-
-
Devon
-
Exeter, Devon, United Kingdom, EX2 5DW
- Royal Devon and Exeter NHS Foundation Trust
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
- Oxford Hospitals NHS Trust
-
-
Teeside
-
Newcastle, Teeside, United Kingdom, NE1 4LP
- Newcastle Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ewan Pearson, University of Dundee
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011DIRECT01 (GLP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
Clinical Trials on Exenatide, Liraglutide
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, Slovakia, Hungary, France, Australia
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, Poland, Puerto Rico, Denmark, Sweden, Austria, Germany, Macedonia, The Former Yugoslav Republic of, Slovenia, France, Switzerland, Norway, Spain, Ireland, Finland, Romania
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusAustralia, France, Italy, Korea, Republic of, Mexico, Spain, Poland, Romania, South Africa, Argentina, Austria, Belgium, Germany, Hungary, Israel, Slovakia, Greece, India, Taiwan, Canada, Czech Republic
-
Cliniques universitaires Saint-Luc- Université...CompletedPsoriasis | Type 2 DiabetesBelgium
-
Katarina KosDiabetes UKCompleted
-
Xiangya Hospital of Central South UniversityRecruiting
-
Xinqiao Hospital of ChongqingUniversity of Messina; Azienda Ospedaliera Universitaria Policlinico "G. Martino...CompletedObesity | Overweight | Polycystic Ovary Syndrome (PCOS)China
-
Amsterdam UMC, location VUmcEU FP7: SAFEGUARD consortiumCompleted
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusUnited States
-
Hanmi Pharmaceutical Company LimitedCompletedType 2 DiabetesUnited States