NCT00788840已完成4 期
A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Treated with metformin
- •Already on treatment with a long-acting or intermediate insulin.
- •Over 18 years of age,
- •HbA1c > 7.0%
- •Able and willing to perform self-blood glucose monitoring.
- •Able and willing to maintain consistent eating habits throughout the entire trial period.
- •Able and willing to maintain consistent physical activity level during the entire trial period
排除标准
- •Patients on sulphonylureas or thiazolidinediones
- •Proliferative retinopathy that has required acute treatment within the last six months.
- •Impaired hepatic or renal functions.
- •Cardiac problems.
- •Uncontrolled hypertension (treated or untreated).
- •Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
研究组 & 干预措施
1. Insulatard
Active Comparator
干预措施: Insulatard (Drug)
2. Detemir
Active Comparator
干预措施: Detemir (Drug)
结局指标
主要结局
Weight change
时间窗: 6 months
次要结局
- Glycaemic control(6 months)
- Energy Expenditure(6 months)
- Fat & muscle gene expression(6 months)
- Fat composition(6 months)
研究者
研究点 (1)
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