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

NHS Foundation Trust

Status: Completed

Conditions: Diabetes

Treatments: Drug: second- or third-line glucose-lowering diabetes treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02105792

12/SW/0347 (Other Identifier)

CRF112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 820 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

820 participants in 2 patient groups

Responders

Description:

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).

Treatment:

Drug: second- or third-line glucose-lowering diabetes treatment

Progressors

Description:

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.