PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
- Conditions
- Diabetes
- Interventions
- Drug: second- or third-line glucose-lowering diabetes treatment
- Registration Number
- NCT02105792
- Lead Sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Brief Summary
This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 820
- Demographics: Age 18-90 inclusive
- Ethnicity: Reflective of local demographic
- Medical History: Clinical diagnosis of Type 2 diabetes
- Mental Capacity: Capacity to Consent
- Age less than 18 years old and greater than 90 years old
- Incapacity to consent
- Type 1 diabetes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Responders second- or third-line glucose-lowering diabetes treatment 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).
- Primary Outcome Measures
Name Time Method Response to diabetes therapy 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.
- Secondary Outcome Measures
Name Time Method Collection of samples for analysis of potential biomarkers 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.
Trial Locations
- Locations (5)
University of Exeter
🇬🇧Exeter, Devon, United Kingdom
University of Newcastle
🇬🇧Newcastle upon Tyne, Tyne And Wear, United Kingdom
King's College University of London
🇬🇧London, United Kingdom
Oxford University Hospitals NHS Trust
🇬🇧Oxford, Oxfordshire, United Kingdom
University of Glasgow
🇬🇧Glasgow, United Kingdom