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

Diabetes Clinical Trial

— RetroMASTER  

Official title:

Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109978
• Other study ID #: CRF117
• Secondary ID: 12/SW/0348
• Status: Completed
• Start date: April 2013
• Est. completion date: May 2015

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 (T2D) therapy using a retrospective approach and patients with slow or fast diabetes progression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee
United Kingdom	University of Exeter	Exeter	Devon
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (6)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	NHS Tayside, Oxford University Hospitals NHS Trust, University of Dundee, University of Exeter, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to diabetes therapy and rate of diabetes progression	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.	Within 9 months from date of recruitment
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