Predicting Response to Incretin Based Agents in Type 2 Diabetes

Type2 Diabetes Clinical Trial

— PRIBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503112
• Other study ID #: 11233581
• Status: Completed
• First received: December 30, 2011
• Last updated: April 17, 2018
• Start date: May 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2018
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 957
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• No intervention, observational study

Locations

Country	Name	City	State
United Kingdom	North Devon NHS Trust	Barnstaple	Devon
United Kingdom	The Royal Bournmouth and Christchurch Hospitals NHS Trust	Bournmouth
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon
United Kingdom	Ipswich Hospital NHS Trust	Ipswich
United Kingdom	Northampton General Hospital NHS Trust	Northampton
United Kingdom	Oxford Radcliffe Hospitals NHS Trust	Oxford
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon
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	Taunton and Somerset NHS Foundation Trust.	Taunton	Somerset
United Kingdom	South Devon Healthcare NHS Foundation Trust	Torbay	Devon
United Kingdom	Cornwall and Isles of Scilly NHS Primary Care Trust	Truro	Cornwall
United Kingdom	South Warwickshire NHS Foundation Trust	Warwick
United Kingdom	West Hertfordshire Hospitals NHS Trust	Watford
United Kingdom	Yeovil Disctrict Hospital NHS Foundation Trust	Yeovil	Somerset

Sponsors (3)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	National Institute for Health Research, United Kingdom, University of Exeter

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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 As — View Citation

Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT; PRIBA Study Group. Markers of ß-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: 10.2 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic response (HbA1c change post treatment)	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	Weight change over 6 months treatment		6 months

External Links

•   Research group website