Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00795600
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description insulin NPH insulin NPH 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 insulin detemir insulin detemir Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
- Primary Outcome Measures
Name Time Method Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) 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 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.
- Secondary Outcome Measures
Name Time Method Absolute Change in Albumin Week 0, week 26 Percentage Change in Whole Body Fat Mass Week 0, week 26 Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.
Absolute Change in Calculated Whole Body Fat Percentage Week 0, week 26 Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio Week 0, week 26 Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol Week 0, week 26 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 Trunk Lean Mass Week 0, week 26 Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate
Percentual Change in Calculated Trunk Fat Percentage Week 0, week 26 Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.
Percentage Change in Trunk Lean Mass Week 0, week 26 Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.
Absolute Change in Whole Body Fat Mass Week 0, week 26 Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Absolute Change in Whole Body Lean Mass Week 0, week 26 Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.
Percentual Change in Calculated Whole Body Fat Percentage Week 0, week 26 Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.
Absolute Change in Calculated Trunk Fat Percentage Week 0, week 26 Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio Week 0, week 26 Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Absolute Change in Free Fatty Acids Week 0, week 26 Percentage Change in Whole Body Lean Mass Week 0, week 26 Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.
Absolute Change in Visceral Adipose Tissue Area Week 0, week 26 Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate
Absolute Change in Subcutaneous Adipose Tissue Area Week 0, week 26 Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate
Absolute Change in Adiponectin Week 0, week 26 Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.
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 Percentage Change in Visceral Adipose Tissue Area Week 0, week 26 Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.
Percentage Change in Subcutaneous Adipose Tissue Area Week 0, week 26 Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.
Absolute Change in Liver/Spleen Attenuation Ratio Week 0, week 26 Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.
Percentage Change in Liver/Spleen Attenuation Ratio Week 0, week 26 Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.
Absolute Change in HbA1c (Glycosylated Haemoglobin) Week 0, week 26 Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.
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 Waist Circumference Week 0, week 26 Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.
Absolute Change in Hip Circumference Week 0, week 26 Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.
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 Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.
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 Monocytes 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 Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.
Number of Hypoglycaemic Episodes Weeks 0-26 Number of episodes reported during the trial.
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 Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.
Number of Non-serious Adverse Events Weeks 0-26 Number of episodes reported during the trial.