A Trial Investigating the Possible Difference in the Development of Type 2 Diabetes in Caucasian and Japanese Subjects by a Model-based Analysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 3
- 主要终点
- Beta-cell function index estimated by a model-based analysis fit to the complete OGTT C-peptide and glucose profiles (12 time points), and including diabetes progression (as assessed by the glucose concentration 2 hours after an oral glucose load)
研究概览
简要总结
This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects with type 2 diabetes will be included in the trial. The development of type 2 diabetes across the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Danish (Northern European) or Japanese (according to country allocation) background for at least 3 generations
- •BMI above or equal to 18 kg/m2
排除标准
- •Treatment of diabetes mellitus with any insulin product
- •Fasting plasma/serum glucose above 12 mM
- •Therapy with TZD (thiazolidinedione) drugs within the past 3 months
- •Therapy with more than 2 OADs (oral anti-diabetics drugs)
结局指标
主要结局
Beta-cell function index estimated by a model-based analysis fit to the complete OGTT C-peptide and glucose profiles (12 time points), and including diabetes progression (as assessed by the glucose concentration 2 hours after an oral glucose load)
时间窗: At 5-hour Oral Glucose Tolerance Test (OGTT)
次要结局
- Fraction of the possible difference in ß-cell function and insulin sensitivity between Japanese and Caucasian that can be explained by each covariate factor(At 5-hour OGTT and 4-hour clamp procedure)
- Evaluation of comparability of OGTT and clamp data based on modelling data of insulin sensitivity from steady-state clamp insulin and glucose concentrations and OGTT insulin and glucose profiles (12 time points)(At 5-hour OGTT and 4-hour clamp procedure)
- Insulin sensitivity estimated by a model-based analysis fit to the complete OGTT insulin and glucose profiles (12 time points)(At 5-hour OGTT and 4-hour clamp procedure)