A 32-week National, Single-centre, Open-labelled, Randomised, Crossover Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-Bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Total Energy Expenditure, Dietary Record Method
研究概览
简要总结
This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.
详细描述
The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 1 diabetes for more than 12 months
- •Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal)
- •HbA1c (glycosylated haemoglobin A1c) between 7.0 and 11.0%
- •Able and willing to maintain consistent physical activity level throughout the entire study period
- •Able and willing to maintain consistent eating habits throughout the entire study period
排除标准
- •Proliferative retinopathy that has required acute treatment within the last six months
- •Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
- •Liver, kidney or heart problems as judged by the Investigator
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
- •Known or suspected allergy to trial products or related products
- •Receipt of any investigational drug within one month prior to this trial
研究组 & 干预措施
Treatment period 1
Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
干预措施: insulin detemir (Drug)
Treatment period 1
Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
干预措施: insulin NPH (Drug)
Treatment period 1
Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
干预措施: insulin aspart (Drug)
Treatment period 2
Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
干预措施: insulin detemir (Drug)
Treatment period 2
Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
干预措施: insulin NPH (Drug)
Treatment period 2
Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
干预措施: insulin aspart (Drug)
结局指标
主要结局
Total Energy Expenditure, Dietary Record Method
时间窗: Weeks 14-16, weeks 30-32
The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.
Total Energy Expenditure, Double-labelled Water Method
时间窗: Weeks 14-16, weeks 30-32
Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.
次要结局
- Component of Total Energy Expenditure: Physical Activity Thermogenesis(Week 16, week 32)
- Body Weight(Week 16, week 32)
- Component of Total Energy Expenditure: Resting Energy Expenditure (REE)(Week 14, week 30)
- Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)(Week 14, week 30)
- Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)(Week 16, week 32)
- Lean Body Mass(Week 16, week 32)
- Waist:Hip Ratio(Week 16, week 32)
- Glycosylated Haemoglobin A1c (HbA1c)(Week 16, week 32)
- Fasting Plasma Glucose(Week 16, week 32)
- Hypoglycaemic Episodes(Weeks 0-32)
- Fat Mass(Week 16, week 32)
- Hormonal Assessment: Adiponectin(Week 14, week 30)
- Hormonal Assessment: Insulin-like Growth Factor-1(Week 14, week 30)
- Hormonal Assessment: Resistin(Week 14, week 30)
- Hormonal Assessment: Leptin(Week 14, week 30)
- Hypoglycaemic Episodes, Diurnal/Nocturnal(Weeks 0-32)