Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795600
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : June 17, 2013
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 21, 2008
Results First Submitted Date  ICMJE August 9, 2011
Results First Posted Date  ICMJE June 17, 2013
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
  • Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
to compare the change in trunk fat mass assessed by DEXA [ Time Frame: at baseline and 26 weeks of treatment. ]
Change History Complete list of historical versions of study NCT00795600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
  • Absolute Change in Whole Body Fat Mass [ Time Frame: 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.
  • Percentage Change in Whole Body Fat Mass [ Time Frame: 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 Whole Body Lean Mass [ Time Frame: 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.
  • Percentage Change in Whole Body Lean Mass [ Time Frame: 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 Trunk Lean Mass [ Time Frame: 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
  • Percentage Change in Trunk Lean Mass [ Time Frame: 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 Calculated Whole Body Fat Percentage [ Time Frame: 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
  • Percentual Change in Calculated Whole Body Fat Percentage [ Time Frame: 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 [ Time Frame: 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
  • Percentual Change in Calculated Trunk Fat Percentage [ Time Frame: 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.
  • Absolute Change in Visceral Adipose Tissue Area [ Time Frame: 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
  • Percentage Change in Visceral Adipose Tissue Area [ Time Frame: 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.
  • Absolute Change in Subcutaneous Adipose Tissue Area [ Time Frame: 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
  • Percentage Change in Subcutaneous Adipose Tissue Area [ Time Frame: 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 Calculated Visceral/Subcutaneous Adipose Tissue Ratio [ Time Frame: 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.
  • Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio [ Time Frame: 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 Liver/Spleen Attenuation Ratio [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 Fasting Plasma Glucose (FPG) [ Time Frame: 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 Adiponectin [ Time Frame: 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 [ Time Frame: Week 0, week 26 ]
  • Absolute Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Triglycerides [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Free Fatty Acids [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Haemoglobin [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Blood Volume (Haematocrit) [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Thrombocytes [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Erythrocytes [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Leucocytes [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Lymphocytes [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Monocytes [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Neutrophils [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Eosinophils [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Basophils [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Creatinine [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Creatine Phosphokinase [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Urea [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Albumin [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Bilirubin Total [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Alanine Aminotransferase (ALAT) [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Aspartate Aminotransferase (ASAT) [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Alkaline Phosphatase [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Sodium [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Potassium [ Time Frame: Week 0, week 26 ]
  • Absolute Change in Body Weight [ Time Frame: 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.
  • Absolute Change in Waist Circumference [ Time Frame: 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 [ Time Frame: 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 hsCRP (Highly Sensitive C Reactive Protein) [ Time Frame: 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.
  • Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) [ Time Frame: Week 0, week 26 ]
  • Number of Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]
    Number of episodes reported during the trial.
  • Number of Non-serious Adverse Events [ Time Frame: Weeks 0-26 ]
    Number of episodes reported during the trial.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
  • additional for DEXA: Whole Body Fat Mass (g), Whole Body Lean Mass (g), Trunk Lean Mass (g), Calculated Whole Body Fat Percentage and Calculated Trunk Fat Percentage [ Time Frame: at baseline and 26 weeks of treatment ]
  • cT scan: Visceral Adipose Tissue Area (cm2), Subcutaneous Adipose Tissue Area (cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio and Liver/Spleen Attenuation Ratio (L/S) [ Time Frame: at baseline and 26 weeks of treatment ]
  • change in HbA1c [ Time Frame: at baseline and 26 weeks of treatment ]
  • change in Fasting Plasma Glucose (FPG) [ Time Frame: at baseline and 26 weeks of treatment ]
  • to quantify the relationship between BMI and required daily dose of insulin detemir [ Time Frame: at baseline and 26 weeks of treatment ]
  • to quantify the cytokine in the adipose tissue (adiponectin) [ Time Frame: at baseline and 26 weeks of treatment ]
  • incidence of hypoglycaemia [ Time Frame: at baseline and 26 weeks of treatment ]
  • lipid profile [ Time Frame: at baseline and 26 weeks of treatment ]
  • incidence of Adverse events during the trial [ Time Frame: at baseline and 26 weeks of treatment ]
  • safety profile as measured by laboratory safety parameters [ Time Frame: at baseline and 26 weeks of treatment ]
  • weight and waist/hip circumference [ Time Frame: at baseline and 26 weeks of treatment ]
  • to quantify the inflammatory parameters (hsCRP and PAI-1) [ Time Frame: at baseline and 26 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: insulin detemir
    Insulin detemir once daily plus insulin aspart at mealtime
  • Drug: insulin NPH
    Insulin NPH once daily plus insulin aspart at mealtime
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: insulin detemir
  • Active Comparator: 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
    Intervention: Drug: insulin NPH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2010)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)
58
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795600
Other Study ID Numbers  ICMJE NN304-3614
2008-003739-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP