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

Novo Nordisk A/S60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Insulin detemir once daily plus insulin aspart at mealtime

insulin NPHDRUG

Insulin NPH once daily plus insulin aspart at mealtime

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Málaga, Spain

Outcomes

Primary Outcomes

Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)

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.

Time frame: week 0, week 26

Absolute Change in Trunk Fat Mass

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.

Time frame: week 0, week 26

Secondary Outcomes

Absolute Change in Whole Body Fat Mass

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.

Time frame: Week 0, week 26

Percentage Change in Whole Body Fat Mass

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.

Time frame: Week 0, week 26

Absolute Change in Whole Body Lean Mass

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.

Time frame: Week 0, week 26

Percentage Change in Whole Body Lean Mass

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.

Time frame: Week 0, week 26

Data from ClinicalTrials.gov

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Absolute Change in Trunk Lean Mass

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

Time frame: Week 0, week 26

Percentage Change in Trunk Lean Mass

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.

Time frame: Week 0, week 26

Absolute Change in Calculated Whole Body Fat Percentage

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

Time frame: Week 0, week 26

Percentual Change in Calculated Whole Body Fat Percentage

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.

Time frame: Week 0, week 26

Absolute Change in Calculated Trunk Fat Percentage

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

Time frame: Week 0, week 26

Percentual Change in Calculated Trunk Fat Percentage

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.

Time frame: Week 0, week 26

Absolute Change in Visceral Adipose Tissue Area

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

Time frame: Week 0, week 26

Percentage Change in Visceral Adipose Tissue Area

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.

Time frame: Week 0, week 26

Absolute Change in Subcutaneous Adipose Tissue Area

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

Time frame: Week 0, week 26

Percentage Change in Subcutaneous Adipose Tissue Area

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.

Time frame: Week 0, week 26

Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio

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.

Time frame: Week 0, week 26

Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio

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.

Time frame: Week 0, week 26

Absolute Change in Liver/Spleen Attenuation Ratio

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.

Time frame: Week 0, week 26

Percentage Change in Liver/Spleen Attenuation Ratio

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.

Time frame: Week 0, week 26

Absolute Change in HbA1c (Glycosylated Haemoglobin)

Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.

Time frame: Week 0, week 26

Absolute Change in Fasting Plasma Glucose (FPG)

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.

Time frame: Week 0, week 26

Absolute Change in Adiponectin

Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.

Time frame: Week 0, week 26

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

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.

Time frame: Week 0, week 26

Absolute Change in Waist Circumference

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.

Time frame: Week 0, week 26

Absolute Change in Hip Circumference

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.

Time frame: Week 0, week 26

Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)

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.

Time frame: Week 0, week 26

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

Time frame: Week 0, week 26

Number of Hypoglycaemic Episodes

Number of episodes reported during the trial.

Time frame: Weeks 0-26

Number of Non-serious Adverse Events

Number of episodes reported during the trial.

Time frame: Weeks 0-26