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OpenTrials
Completed

NCT Number: NCT00795600

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Málaga, 29009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Insulin detemir once daily plus insulin aspart at mealtime

insulin NPH

Drug

Insulin NPH once daily plus insulin aspart at mealtime

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. Absolute Change in Total Cholesterol

    Time frame: Week 0, week 26

  23. Absolute Change in High Density Lipoprotein (HDL) Cholesterol

    Time frame: Week 0, week 26

  24. Absolute Change in Low Density Lipoprotein (LDL) Cholesterol

    Time frame: Week 0, week 26

  25. Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol

    Time frame: Week 0, week 26

  26. Absolute Change in Triglycerides

    Time frame: Week 0, week 26

  27. Absolute Change in Free Fatty Acids

    Time frame: Week 0, week 26

  28. Absolute Change in Haemoglobin

    Time frame: Week 0, week 26

  29. Absolute Change in Blood Volume (Haematocrit)

    Time frame: Week 0, week 26

  30. Absolute Change in Thrombocytes

    Time frame: Week 0, week 26

  31. Absolute Change in Erythrocytes

    Time frame: Week 0, week 26

  32. Absolute Change in Leucocytes

    Time frame: Week 0, week 26

  33. Absolute Change in Lymphocytes

    Time frame: Week 0, week 26

  34. Absolute Change in Monocytes

    Time frame: Week 0, week 26

  35. Absolute Change in Neutrophils

    Time frame: Week 0, week 26

  36. Absolute Change in Eosinophils

    Time frame: Week 0, week 26

  37. Absolute Change in Basophils

    Time frame: Week 0, week 26

  38. Absolute Change in Creatinine

    Time frame: Week 0, week 26

  39. Absolute Change in Creatine Phosphokinase

    Time frame: Week 0, week 26

  40. Absolute Change in Urea

    Time frame: Week 0, week 26

  41. Absolute Change in Albumin

    Time frame: Week 0, week 26

  42. Absolute Change in Bilirubin Total

    Time frame: Week 0, week 26

  43. Absolute Change in Alanine Aminotransferase (ALAT)

    Time frame: Week 0, week 26

  44. Absolute Change in Aspartate Aminotransferase (ASAT)

    Time frame: Week 0, week 26

  45. Absolute Change in Alkaline Phosphatase

    Time frame: Week 0, week 26

  46. Absolute Change in Sodium

    Time frame: Week 0, week 26

  47. Absolute Change in Potassium

    Time frame: Week 0, week 26

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)

    Time frame: Week 0, week 26

  53. Number of Hypoglycaemic Episodes

    Time frame: Weeks 0-26

    Number of episodes reported during the trial.

  54. Number of Non-serious Adverse Events

    Time frame: Weeks 0-26

    Number of episodes reported during the trial.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2008
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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