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

NHS Foundation Trust

Status: Completed

Conditions: Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT02109978

CRF117

12/SW/0348 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 562 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Generic 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.

Trial design

562 participants in 2 patient groups

Responders

Description:

Patients with Type 2 diabetes that have been taking a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors, Glitazone or insulin) for at least 4 months.

Progressors

Description:

Patients with Type 2 diabetes that progressed to requiring insulin treatment ≤10 years from diagnosis or have had no requirement for insulin treatment \>10 years from diagnosis.