PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

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.
    

Intervention name(s): second- or third-line glucose-lowering diabetes treatment
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Sulphonylurea; DPP-4 inhibitor; GLP-1R agonist; SGLT2 inhibitor; Glitazone
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be identified in primary care and secondary care. The method for patient
        identification may differ between sites and could involve:

        GP Searches; Secondary Care Clinician Referral; Research Database Searches.
      
Biospecimen description: 
      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.
    
Keywords: Diabetes; Type 2 diabetes; Diabetes therapy response; Diabetes progression