RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

Completed

• Conditions: Diabetes

• Registration Number: NCT02109978
• 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 (T2D) therapy using a retrospective approach and patients with slow or fast diabetes progression.

Detailed Description

PILOT Phase (March 2013 - Dec 2014) Patients will be recruited initially from 2 centres, plus Exeter as a pre-PILOT centre. Patients with particularly good or poor response to second- and third-line Type 2 diabetes treatments and patients progressing to insulin either particularly quickly or particularly slowly will be recruited from primary, secondary, or community settings. Fasting blood and urine samples will be collected, along with standard biomeasures and information will be collected about medical history and prescribing history.

All study documentation and sample materials will be sent out to sites from the coordinating centre. Sites will be expected to process and freeze samples and send them to the Central Laboratory managed by the Chief Inspector's site 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 project will continue for another three years.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 562

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

Responders Cohort Inclusion Criteria:

• On Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone for > 4 months.
• Pre-treatment HbA1c≥ 58mmol/mol (7.5%).

Progressors Cohort Inclusion Criteria:

• Type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
• Either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or HbA1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment >10 years from diagnosis (defined as not on insulin treatment AND HbA1c <69mmol/mol (8.5%).

Exclusion Criteria

• 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

Primary Outcome Measures

Name	Time	Method
Response to diabetes therapy and rate of diabetes progression	Within 9 months from date of recruitment	The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or poor response to specific second- and third- line classes of treatment for Type 2 diabetes; and of those patients that show rapid progression of Type 2 diabetes or slow progression of Type 2 diabetes to markedly high blood glucose despite the treatment that they require.

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 (3)

University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom

University of Dundee; 🇬🇧 Dundee, United Kingdom

University of Oxford; 🇬🇧 Oxford, Oxfordshire, United Kingdom