DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 8
- 主要终点
- Change in HbA1c between baseline and 6 months
研究概览
简要总结
The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.
详细描述
To develop a cohort of patients treated with GLP-1 R Agonists who are phenotyped at baseline and at 6 month follow up to determine clinical, imaging and other biomarker predictors of glycaemic response to GLP-1R Agonists. The hypothesis is that one, or a combination, of these biomarkers is associated with glycaemic response to GLP-1R Agonists. The primary outcome is therefore HbA1c reduction after 6 months of GLP-1R A treatment.
This is a cohort study of 800 patients being treated with either exenatide or liraglutide for 6 months, and carried out in 4 UK centres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist
- •On any combination of oral hypoglycaemic agents
- •On Insulin (+/- oral hypoglycaemic agents)
- •HbA1c ≥7.5% (58mmol/mol) and HbA1c < 12% (108mmol/mol)
- •White European
- •Age ≥ 18 and < 80
排除标准
- •Type 1 diabetes
- •HbA1c <7.5% (58 mmol/mol)
- •HbA1c ≥ 12% (108 mmol/mol)
- •Pregnancy or lactation
- •Any other significant medical reason for exclusion as determined by the investigator
- •Inability to consent
- •Participating in a CTIMP during the study period and within 30 days prior to study start.
结局指标
主要结局
Change in HbA1c between baseline and 6 months
时间窗: 6 months
The primary outcome is the change in HbA1c (absolute difference between the baseline and 6 month measure) in mmol/mol
次要结局
未报告次要终点
研究者
Ewan Pearson
Chief Investigator
University of Dundee