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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
Sponsor:
Collaborators:
University of Exeter
King's College London
King's College Hospital NHS Trust
University of Glasgow
NHS Greater Glasgow and Clyde
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Drug: second- or third-line glucose-lowering diabetes treatment

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.

Study Design
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Study Type : Observational
Actual Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Groups and Cohorts
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Group/Cohort Intervention/treatment
Responders
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.
Other Names:
  • Sulphonylurea
  • DPP-4 inhibitor
  • GLP-1R agonist
  • SGLT2 inhibitor
  • Glitazone
Progressors
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Demographics: Age 18-90 inclusive
  • Ethnicity: Reflective of local demographic
  • Medical History: Clinical diagnosis of Type 2 diabetes
  • Mental Capacity: Capacity to Consent

Exclusion Criteria:

  • Age less than 18 years old and greater than 90 years old
  • Incapacity to consent
  • Type 1 diabetes.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
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
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
University of Exeter
King's College London
King's College Hospital NHS Trust
University of Glasgow
NHS Greater Glasgow and Clyde
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Andrew T Hattersley, FRCP, DM, BM University of Exeter
More Information
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Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02105792    
Other Study ID Numbers: CRF112
12/SW/0347 ( Other Identifier: Research Ethics Committee )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Diabetes
Type 2 diabetes
Diabetes therapy response
Diabetes progression
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
 Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors