Predicting Response to Incretin Based Agents in Type 2 Diabetes (PRIBA)

April 17, 2018 updated by: Angus Jones, Royal Devon and Exeter NHS Foundation Trust

Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

957

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournmouth, United Kingdom, BH7 7DW
        • The Royal Bournmouth and Christchurch Hospitals NHS Trust
      • Bristol, United Kingdom, BS10 5NB
        • North Bristol NHS Trust
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust
      • Northampton, United Kingdom, NN15BD
        • Northampton General Hospital NHS Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford Radcliffe Hospitals NHS Trust
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust
      • Redhill, United Kingdom, RH1 5RH
        • Surrey and Sussex Healthcare NHS Trust
      • St Leonards-on-Sea, United Kingdom, TN37 7RD
        • East Sussex Healthcare NHS Trust
      • Stoke on Trent, United Kingdom, ST4 7LN
        • University Hospitls North Staffordshire NHS Trust
      • Warwick, United Kingdom, CV34 5BW
        • South Warwickshire NHS Foundation Trust
      • Watford, United Kingdom, WD18 0HB
        • West Hertfordshire Hospitals NHS Trust
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR13HD
        • Cornwall and Isles of Scilly NHS Primary Care Trust
    • Devon
      • Barnstaple, Devon, United Kingdom, EX314JB
        • North Devon NHS Trust
      • Exeter, Devon, United Kingdom, EX25DW
        • Royal Devon and Exeter NHS Foundation Trust
      • Plymouth, Devon, United Kingdom, PL68DH
        • Plymouth Hospitals NHS Trust
      • Torbay, Devon, United Kingdom, TQ27AA
        • South Devon Healthcare NHS Foundation Trust
    • Somerset
      • Taunton, Somerset, United Kingdom, BA228HR
        • Taunton and Somerset NHS Foundation Trust.
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Yeovil Disctrict Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 Diabetes commencing DPP-IV inhibitors or GLP-1 agonsists in primary or secondary care in England

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients starting incretin treatments
Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.
Other: No intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic response (HbA1c change post treatment)
Time Frame: 6 months
Change in HbA1c over 6 months treatment (as a continuous variable and/or defined as binary response/non response). Our Primary analysis will be the relationship between insulin secretion (as measured by blood C-peptide or UCPCR) and glycaemic response. Secondary analysis will include examination of relationship between baseline weight, HbA1c, age, duration of diabetes, HOMA B, HOMA IR, autoantibody (GAD, IA2) status and glycaemic response. We will also examine the relationship between glycaemic response and polymorphisms in GLP-1R, TCF7L2, WFS1 and FOX01 genes.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight change over 6 months treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Collaborators

National Institute for Health Research, United Kingdom
University of Exeter

Investigators

  • Study Director: Andrew T Hattersley, University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust
  • Principal Investigator: Angus Jones, University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (Estimate)

January 2, 2012

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11233581

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.

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