NCT00795600已完成4 期
A Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, Both With Insulin Aspart at Mealtimes
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
- 60
- 主要终点
- Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
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
- •Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
- •Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
- •Body Mass Index (BMI) between 27.5-40 kg/m^2
排除标准
- •Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
- •Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
- •Previous or planned surgical treatment of obesity
- •Total daily insulin dose higher or equal 2 IU/kg
- •Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
- •Receipt of any investigational drug within 1 month prior to this trial
- •Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
研究组 & 干预措施
insulin detemir
Experimental
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
干预措施: insulin detemir (Drug)
insulin NPH
Active Comparator
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
干预措施: insulin NPH (Drug)
结局指标
主要结局
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
时间窗: week 0, week 26
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Absolute Change in Trunk Fat Mass
时间窗: week 0, week 26
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
次要结局
- Absolute Change in Thrombocytes(Week 0, week 26)
- Absolute Change in Lymphocytes(Week 0, week 26)
- Absolute Change in Neutrophils(Week 0, week 26)
- Absolute Change in Albumin(Week 0, week 26)
- Percentage Change in Whole Body Fat Mass(Week 0, week 26)
- Absolute Change in Calculated Whole Body Fat Percentage(Week 0, week 26)
- Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio(Week 0, week 26)
- Absolute Change in Low Density Lipoprotein (LDL) Cholesterol(Week 0, week 26)
- Absolute Change in Trunk Lean Mass(Week 0, week 26)
- Percentual Change in Calculated Trunk Fat Percentage(Week 0, week 26)
- Percentage Change in Trunk Lean Mass(Week 0, week 26)
- Absolute Change in Whole Body Fat Mass(Week 0, week 26)
- Absolute Change in Whole Body Lean Mass(Week 0, week 26)
- Percentual Change in Calculated Whole Body Fat Percentage(Week 0, week 26)
- Absolute Change in Calculated Trunk Fat Percentage(Week 0, week 26)
- Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio(Week 0, week 26)
- Absolute Change in Free Fatty Acids(Week 0, week 26)
- Percentage Change in Whole Body Lean Mass(Week 0, week 26)
- Absolute Change in Visceral Adipose Tissue Area(Week 0, week 26)
- Absolute Change in Subcutaneous Adipose Tissue Area(Week 0, week 26)
- Absolute Change in Adiponectin(Week 0, week 26)
- Absolute Change in Total Cholesterol(Week 0, week 26)
- Absolute Change in Blood Volume (Haematocrit)(Week 0, week 26)
- Absolute Change in Creatine Phosphokinase(Week 0, week 26)
- Absolute Change in Urea(Week 0, week 26)
- Absolute Change in Haemoglobin(Week 0, week 26)
- Absolute Change in Waist Circumference(Week 0, week 26)
- Absolute Change in Monocytes(Week 0, week 26)
- Percentage Change in Visceral Adipose Tissue Area(Week 0, week 26)
- Percentage Change in Subcutaneous Adipose Tissue Area(Week 0, week 26)
- Absolute Change in Liver/Spleen Attenuation Ratio(Week 0, week 26)
- Percentage Change in Liver/Spleen Attenuation Ratio(Week 0, week 26)
- Absolute Change in HbA1c (Glycosylated Haemoglobin)(Week 0, week 26)
- Absolute Change in Eosinophils(Week 0, week 26)
- Absolute Change in Basophils(Week 0, week 26)
- Absolute Change in Creatinine(Week 0, week 26)
- Absolute Change in Alanine Aminotransferase (ALAT)(Week 0, week 26)
- Absolute Change in Hip Circumference(Week 0, week 26)
- Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)(Week 0, week 26)
- Absolute Change in Fasting Plasma Glucose (FPG)(Week 0, week 26)
- Absolute Change in High Density Lipoprotein (HDL) Cholesterol(Week 0, week 26)
- Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol(Week 0, week 26)
- Absolute Change in Triglycerides(Week 0, week 26)
- Absolute Change in Erythrocytes(Week 0, week 26)
- Absolute Change in Leucocytes(Week 0, week 26)
- Absolute Change in Bilirubin Total(Week 0, week 26)
- Absolute Change in Alkaline Phosphatase(Week 0, week 26)
- Absolute Change in Sodium(Week 0, week 26)
- Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)(Week 0, week 26)
- Number of Hypoglycaemic Episodes(Weeks 0-26)
- Absolute Change in Aspartate Aminotransferase (ASAT)(Week 0, week 26)
- Absolute Change in Potassium(Week 0, week 26)
- Absolute Change in Body Weight(Week 0, week 26)
- Number of Non-serious Adverse Events(Weeks 0-26)
研究者
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