Predicting Response to Incretin Based Agents in Type 2 Diabetes

NCT ID: NCT01503112

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

957 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-04-30

Brief Summary

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Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the blood glucose (sugar) from going too high helps prevent complications. Recently a number of new treatments (collectively called 'incretin based' treatments) to lower blood glucose have become available but response is very variable and it is difficult to predict which will work for an individual. The investigators want to see if we can identify whether the new treatments are likely to be effective for an individual patient. Identifying the right treatment would improve control and minimise the side-effects and costs from ineffective treatments. We will collect blood (for measures of blood glucose, insulin secretion and genetics information), urine (for a simple measurement of insulin secretion) and other clinical information (such as weight,age, duration of diabetes and medication) in people who are about to start these new 'incretin based' treatments and assess their response over the first 6 months of treatment. We will analyse this information to see if we can predict treatment response.

Study Hypothesis:

The investigators hypothesise that those who have low insulin secretion, as measured by post meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose response to incretin based treatments.

Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients starting incretin treatments

Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.

No intervention, observational study

Intervention Type OTHER

Interventions

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No intervention, observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A clinical diagnosis of type 2 diabetes mellitus where the patient's clinician has determined the need for a DPP-IV inhibitor or GLP-1 analogue as a result of inadequate glycaemic control
* HbA1c \>= 58mmol/mol

Exclusion Criteria

* Treatment with DPP-IV inhibitors or GLP-1 analogues prior to study initiation (within the previous 3 months)
* Renal failure as shown by a eGFR (estimated glomerular filtration rate) less than 30 mL/min/1.73m2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role collaborator

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Angus Jones

NIHR Doctoral Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew T Hattersley

Role: STUDY_DIRECTOR

University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust

Angus Jones

Role: PRINCIPAL_INVESTIGATOR

University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust

Locations

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Cornwall and Isles of Scilly NHS Primary Care Trust

Truro, Cornwall, United Kingdom

Site Status

North Devon NHS Trust

Barnstaple, Devon, United Kingdom

Site Status

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, United Kingdom

Site Status

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Site Status

South Devon Healthcare NHS Foundation Trust

Torbay, Devon, United Kingdom

Site Status

Taunton and Somerset NHS Foundation Trust.

Taunton, Somerset, United Kingdom

Site Status

Yeovil Disctrict Hospital NHS Foundation Trust

Yeovil, Somerset, United Kingdom

Site Status

The Royal Bournmouth and Christchurch Hospitals NHS Trust

Bournmouth, , United Kingdom

Site Status

North Bristol NHS Trust

Bristol, , United Kingdom

Site Status

Ipswich Hospital NHS Trust

Ipswich, , United Kingdom

Site Status

Northampton General Hospital NHS Trust

Northampton, , United Kingdom

Site Status

Oxford Radcliffe Hospitals NHS Trust

Oxford, , United Kingdom

Site Status

Portsmouth Hospitals NHS Trust

Portsmouth, , United Kingdom

Site Status

Surrey and Sussex Healthcare NHS trust

Redhill, , United Kingdom

Site Status

East Sussex Healthcare NHS Trust

Saint Leonards-on-Sea, , United Kingdom

Site Status

University Hospitls North Staffordshire NHS Trust

Stoke-on-Trent, , United Kingdom

Site Status

South Warwickshire NHS Foundation Trust

Warwick, , United Kingdom

Site Status

West Hertfordshire Hospitals NHS Trust

Watford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT; PRIBA Study Group. Markers of beta-Cell Failure Predict Poor Glycemic Response to GLP-1 Receptor Agonist Therapy in Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):250-7. doi: 10.2337/dc15-0258. Epub 2015 Aug 4.

Reference Type RESULT
PMID: 26242184 (View on PubMed)

Dennis JM, Shields BM, Hill AV, Knight BA, McDonald TJ, Rodgers LR, Weedon MN, Henley WE, Sattar N, Holman RR, Pearson ER, Hattersley AT, Jones AG; MASTERMIND Consortium. Precision Medicine in Type 2 Diabetes: Clinical Markers of Insulin Resistance Are Associated With Altered Short- and Long-term Glycemic Response to DPP-4 Inhibitor Therapy. Diabetes Care. 2018 Apr;41(4):705-712. doi: 10.2337/dc17-1827. Epub 2018 Jan 31.

Reference Type RESULT
PMID: 29386249 (View on PubMed)

Jones AG, Shields BM, Hyde CJ, Henley WE, Hattersley AT. Identifying good responders to glucose lowering therapy in type 2 diabetes: implications for stratified medicine. PLoS One. 2014 Oct 23;9(10):e111235. doi: 10.1371/journal.pone.0111235. eCollection 2014.

Reference Type RESULT
PMID: 25340784 (View on PubMed)

Related Links

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http://www.diabetesgenes.org

Research group website

Other Identifiers

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11233581

Identifier Type: -

Identifier Source: org_study_id

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