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

This study has been completed.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Exeter
Information provided by (Responsible Party):
Angus Jones, Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01503112
First received: December 30, 2011
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes,
Other: No intervention, observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes

Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:

Primary Outcome Measures:
  • Glycaemic response (HbA1c change post treatment) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Weight change over 6 months treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Extracted DNA, stored serum/plasma


Enrollment: 957
Study Start Date: May 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients starting incretin treatments
Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.
Other: No intervention, observational study
None

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503112

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

Additional Information:
No publications provided

Responsible Party: Angus Jones, NIHR Doctoral Research Fellow, Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01503112     History of Changes
Other Study ID Numbers: 11233581
Study First Received: December 30, 2011
Last Updated: November 4, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Glucagon-Like Peptide 1, DPP4 protein, Therapeutics, Hypoglycemic Agents, C-Peptide, Type 2 Diabetes Mellitus,

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 31, 2015