Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 562
- 试验地点
- 3
- 主要终点
- Response to diabetes therapy and rate of diabetes progression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%).
排除标准
- •Age less than 18 years old and greater than 90 years old
- •Incapacity to consent
- •Type 1 diabetes.
结局指标
主要结局
Response to diabetes therapy and rate of diabetes progression
时间窗: 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.
次要结局
- Collection of samples for analysis of potential biomarkers(within 9 months of recruitment date)