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| ID | Type | Description | Link |
|---|---|---|---|
| 12/SW/0348 | Other Identifier | Research Ethics Committee |
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| Name | Class |
|---|---|
| University of Exeter | OTHER |
| University of Oxford | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| University of Dundee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responders | 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 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Generic Inclusion Criteria:
Responders Cohort Inclusion Criteria:
Progressors Cohort Inclusion Criteria:
Exclusion Criteria:
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Participants will be identified in primary care and secondary care. The method for patient identification may differ between sites and could involve:
GP Searches; Secondary Care Clinician Referral; Research Database Searches.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew T Hattersley, FRCP, DM, BM | University of Exeter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Exeter | Exeter | Devon | EX2 5DW | United Kingdom | ||
| University of Oxford |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER |
| NHS Tayside | OTHER_GOV |
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At Visit 1 a fasting blood sample (approximately 35 mls) will be taken for DNA extraction, and to measure for markers of the progression of diabetes or response to diabetes medication and for secondary markers that may predict response. A urine sample is also collected to measure for biomarkers.
| Oxford |
| Oxfordshire |
| OX1 2JD |
| United Kingdom |
| University of Dundee | Dundee | DD1 9SY | United Kingdom |