PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

Diabetes Clinical Trial

— PROMASTER  

Official title:

PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105792
• Other study ID #: CRF112
• Secondary ID: 12/SW/0347
• Status: Completed
• Start date: March 2013
• Est. completion date: May 2016

Study information

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

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter	Devon
United Kingdom	University of Glasgow	Glasgow
United Kingdom	King's College University of London	London
United Kingdom	University of Newcastle	Newcastle upon Tyne	Tyne And Wear
United Kingdom	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (9)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	King's College Hospital NHS Trust, King's College London, Newcastle University, Newcastle-upon-Tyne Hospitals NHS Trust, NHS Greater Glasgow and Clyde, Oxford University Hospitals NHS Trust, University of Exeter, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to diabetes 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.	Up to 9 months from commencement of new therapy
Secondary	Collection of samples for analysis of potential biomarkers	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.	within 9 months of recruitment date