PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes (PROMASTER)
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|ClinicalTrials.gov Identifier: NCT02105792|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : June 21, 2018
|Condition or disease||Intervention/treatment|
|Diabetes||Drug: second- or third-line glucose-lowering diabetes treatment|
PILOT Phase (March 2013 - Dec 2014) Participants will be recruited initially from 4 centres. Patients due to start second- and third-line Type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. Fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. Participants in Responders Arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. If a 3 month HbA1c has not been collected as part of routine clinical care, the research team will arrange this. Participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. This visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change.
All study documentation and sample materials will be distributed to sites from the Coordinating Centre. Sites will be expected to process and freeze samples and send them to the Chief Investigator's Central Laboratory where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response.
POST-PILOT Phase (Jan 2015 - Oct 2017) Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this study will continue for another 3 years.
|Study Type :||Observational|
|Actual Enrollment :||820 participants|
|Official Title:||PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2016|
Patients with Type 2 diabetes about to commence a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors or Glitazone or insulin).
Drug: second- or third-line glucose-lowering diabetes treatment
Observation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy.
Patients with Type 2 diabetes that progress to requiring insulin treatment ≤10 years from diagnosis or have no requirement for insulin treatment >10 years from diagnosis.
- Response to diabetes therapy [ Time Frame: Up to 9 months from commencement of new therapy ]The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or a poor response to specific second- and third-line classes of treatment for Type 2 diabetes.
- Collection of samples for analysis of potential biomarkers [ Time Frame: within 9 months of recruitment date ]To collect a set of DNA, serum and urine samples to allow analysis of potential genetic and non genetic biomarkers for drug response and diabetes progression.
Biospecimen Retention: Samples With DNA
At Visit 1, a fasting blood sample (approximately 35 ml) will be collected for DNA extraction, and to measure for markers of the progression of diabetes or response to diabetes medication and for secondary markers that may predict response. A urine sample is also collected to measure for biomarkers.
At Visit 2 a fasting blood sample and urine sample will be collected to measure for markers of the response to diabetes medication and for secondary markers that may predict response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105792
|University of Exeter|
|Exeter, Devon, United Kingdom, EX2 5DW|
|Oxford University Hospitals NHS Trust|
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|University of Newcastle|
|Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 7RU|
|University of Glasgow|
|Glasgow, United Kingdom, G12 8TA|
|King's College University of London|
|London, United Kingdom, SE1 9NH|
|Principal Investigator:||Andrew T Hattersley, FRCP, DM, BM||University of Exeter|