Predicting Response to Incretin Based Agents in Type 2 Diabetes
- Conditions
- Type2 Diabetes
- Interventions
- Other: No intervention, observational study
- Registration Number
- NCT01503112
- Lead Sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 957
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients starting incretin treatments No intervention, observational study Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.
- Primary Outcome Measures
Name Time Method Glycaemic response (HbA1c change post treatment) 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.
- Secondary Outcome Measures
Name Time Method Weight change over 6 months treatment 6 months
Trial Locations
- Locations (18)
South Devon Healthcare NHS Foundation Trust
🇬🇧Torbay, Devon, United Kingdom
Yeovil Disctrict Hospital NHS Foundation Trust
🇬🇧Yeovil, Somerset, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, United Kingdom
Cornwall and Isles of Scilly NHS Primary Care Trust
🇬🇧Truro, Cornwall, United Kingdom
North Devon NHS Trust
🇬🇧Barnstaple, Devon, United Kingdom
The Royal Bournmouth and Christchurch Hospitals NHS Trust
🇬🇧Bournmouth, United Kingdom
Oxford Radcliffe Hospitals NHS Trust
🇬🇧Oxford, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, Devon, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, Devon, United Kingdom
Taunton and Somerset NHS Foundation Trust.
🇬🇧Taunton, Somerset, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, United Kingdom
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
Surrey and Sussex Healthcare NHS trust
🇬🇧Redhill, United Kingdom
East Sussex Healthcare NHS Trust
🇬🇧St Leonards-on-Sea, United Kingdom
University Hospitls North Staffordshire NHS Trust
🇬🇧Stoke on Trent, United Kingdom
South Warwickshire NHS Foundation Trust
🇬🇧Warwick, United Kingdom
West Hertfordshire Hospitals NHS Trust
🇬🇧Watford, United Kingdom