CompletedNCT00795600Updated Mar 16, 2016Results posted

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

A Phase 4 interventional study of insulin detemir and insulin NPH in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Diabetes
Diabetes Mellitus, Type 2

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In context

Diabetes Mellitus

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This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

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Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

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
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
Drug: insulin NPH

Interventions

Druginsulin detemir
Insulin detemir once daily plus insulin aspart at mealtime
Druginsulin NPH
Insulin NPH once daily plus insulin aspart at mealtime

What researchers measure

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
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

Results

Posted Jun 17, 2013

Participant flow

Recruitment from 29-Apr-2009 until 02-Feb-2010. 5 sites in Spain.

Participant flow — Overall Study
Milestone	Insulin Detemir	Insulin NPH
Started	25	35
Exposed to drug	24	35
Completed	21	31
Not completed	4	4
Withdrew: Adverse event	1	1
Withdrew: Protocol violation	1	2
Withdrew: Withdrawal by subject	1	0
Withdrew: Unclassified	1	1

Outcome measures

PrimaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)	0.366 ± 2.785	1.011 ± 2.158

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.849 (H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.) · Mean difference (final values): -0.645 · 95% CI -7.404 to 6.114

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

Time frame:: week 0, week 26
Reported as:: Least squares mean · percent change

Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)	0.535 ± 2.875	1.126 ± 2.212

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.948 (H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.) · Mean difference (final values): -0.590 · 95% CI -7.588 to 6.407

PrimaryAbsolute 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
Reported as:: Least squares mean · grams (g)

Absolute Change in Trunk Fat Mass
grams (g)	Insulin Detemir	Insulin NPH
Absolute Change in Trunk Fat Mass	133.99 ± 412.88	-62.37 ± 320.00

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.696 (H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.) · Mean difference (final values): 196.36 · 95% CI -805.8 to 1198.5

PrimaryAbsolute 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
Reported as:: Least squares mean · grams (g)

Absolute Change in Trunk Fat Mass
grams (g)	Insulin Detemir	Insulin NPH
Absolute Change in Trunk Fat Mass	153.38 ± 423.93	39.43 ± 327.78

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.710 (H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.) · Mean difference (final values): 192.81 · 95% CI -844.0 to 1229.7

SecondaryAbsolute 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
Reported as:: Least squares mean · grams (g)

Absolute Change in Whole Body Fat Mass
grams (g)	Insulin Detemir	Insulin NPH
Absolute Change in Whole Body Fat Mass	1147.1 ± 635.79	858.88 ± 494.14

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.709 · Mean difference (final values): 288.21 · 95% CI -1252.0 to 1828.4

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Whole Body Fat Mass
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Whole Body Fat Mass	3.870 ± 2.267	4.047 ± 1.762

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.948 · Mean difference (final values): -0.178 · 95% CI -5.668 to 5.313

SecondaryAbsolute 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
Reported as:: Least squares mean · grams (g)

Absolute Change in Whole Body Lean Mass
grams (g)	Insulin Detemir	Insulin NPH
Absolute Change in Whole Body Lean Mass	-54.20 ± 673.32	1097.2 ± 524.74

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.162 · Mean difference (final values): -1151.0 · 95% CI -2780.0 to 477.33

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Whole Body Lean Mass
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Whole Body Lean Mass	0.051 ± 1.485	2.798 ± 1.158

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.131 · Mean difference (final values): -2.747 · 95% CI -6.340 to 0.846

SecondaryAbsolute 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
Reported as:: Least squares mean · grams (g)

Absolute Change in Trunk Lean Mass
grams (g)	Insulin Detemir	Insulin NPH
Absolute Change in Trunk Lean Mass	359.43 ± 306.47	469.84 ± 238.67

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.766 · Mean difference (final values): -110.4 · 95% CI -851.3 to 630.51

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Trunk Lean Mass
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Trunk Lean Mass	1.480 ± 1.381	2.090 ± 1.076

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.716 · Mean difference (final values): -0.610 · 95% CI -3.949 to 2.729

SecondaryAbsolute 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
Reported as:: Least squares mean · percent of whole body fat (%)

Absolute Change in Calculated Whole Body Fat Percentage
percent of whole body fat (%)	Insulin Detemir	Insulin NPH
Absolute Change in Calculated Whole Body Fat Percentage	0.782 ± 0.578	0.291 ± 0.450

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.483 · Mean difference (final values): 0.491 · 95% CI -0.906 to 1.888

SecondaryPercentual 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
Reported as:: Least squares mean · percent change

Percentual Change in Calculated Whole Body Fat Percentage
percent change	Insulin Detemir	Insulin NPH
Percentual Change in Calculated Whole Body Fat Percentage	1.607 ± 1.587	1.491 ± 1.235

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.952 · Mean difference (final values): 0.116 · 95% CI -3.721 to 3.953

SecondaryAbsolute 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
Reported as:: Least squares mean · percent of trunk fat (%)

Absolute Change in Calculated Trunk Fat Percentage
percent of trunk fat (%)	Insulin Detemir	Insulin NPH
Absolute Change in Calculated Trunk Fat Percentage	-0.600 ± 0.621	-0.321 ± 0.483

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.711 · Mean difference (final values): -0.278 · 95% CI -1.778 to 1.221

SecondaryPercentual 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
Reported as:: Least squares mean · percent change

Percentual Change in Calculated Trunk Fat Percentage
percent change	Insulin Detemir	Insulin NPH
Percentual Change in Calculated Trunk Fat Percentage	-1.543 ± 1.542	0.042 ± 1.201

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.397 · Mean difference (final values): -1.585 · 95% CI -5.310 to 2.141

SecondaryAbsolute 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
Reported as:: Least squares mean · cm^2

Absolute Change in Visceral Adipose Tissue Area
cm^2	Insulin Detemir	Insulin NPH
Absolute Change in Visceral Adipose Tissue Area	-3.258 ± 9.122	5.658 ± 7.042

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.421 · Mean difference (final values): -8.916 · 95% CI -30.99 to 13.159

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Visceral Adipose Tissue Area
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Visceral Adipose Tissue Area	-0.535 ± 5.162	4.526 ± 3.4985

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.420 · Mean difference (final values): -5.061 · 95% CI -17.55 to 7.430

SecondaryAbsolute 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
Reported as:: Least squares mean · cm^2

Absolute Change in Subcutaneous Adipose Tissue Area
cm^2	Insulin Detemir	Insulin NPH
Absolute Change in Subcutaneous Adipose Tissue Area	7.654 ± 10.764	12.616 ± 8.375

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.705 · Mean difference (final values): -4.961 · 95% CI -31.10 to 21.178

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Subcutaneous Adipose Tissue Area
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Subcutaneous Adipose Tissue Area	1.153 ± 3.952	5.743 ± 3.075

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.341 · Mean difference (final values): -4.590 · 95% CI -14.19 to 5.007

SecondaryAbsolute 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
Reported as:: Least squares mean · ratio

Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
ratio	Insulin Detemir	Insulin NPH
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio	-0.032 ± 0.028	-0.036 ± 0.022

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.902 · Mean difference (final values): 0.004 · 95% CI -0.064 to 0.073

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio	-4.092 ± 3.211	-3.303 ± 2.493

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.839 · Mean difference (final values): -0.789 · 95% CI -8.525 to 6.947

SecondaryAbsolute 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
Reported as:: Least squares mean · ratio

Absolute Change in Liver/Spleen Attenuation Ratio
ratio	Insulin Detemir	Insulin NPH
Absolute Change in Liver/Spleen Attenuation Ratio	-0.044 ± 0.035	-0.023 ± 0.026

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.607 · Mean difference (final values): -0.021 · 95% CI -0.105 to 0.062

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage Change in Liver/Spleen Attenuation Ratio
percent change	Insulin Detemir	Insulin NPH
Percentage Change in Liver/Spleen Attenuation Ratio	-2.632 ± 3.102	-0.855 ± 2.355

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.635 · Mean difference (final values): -1.777 · 95% CI -9.254 to 5.700

SecondaryAbsolute 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
Reported as:: Least squares mean · percentage of glycosylated haemoglobin

Absolute Change in HbA1c (Glycosylated Haemoglobin)
percentage of glycosylated haemoglobin	Insulin Detemir	Insulin NPH
Absolute Change in HbA1c (Glycosylated Haemoglobin)	-0.922 ± 0.226	-0.792 ± 0.172

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.628 · Mean difference (final values): -0.130 · 95% CI -0.663 to 0.403

SecondaryAbsolute 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
Reported as:: Least squares mean · mg/dL

Absolute Change in Fasting Plasma Glucose (FPG)
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Fasting Plasma Glucose (FPG)	-48.29 ± 14.599	-37.36 ± 11.616

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.535 · Mean difference (final values): -10.92 · 95% CI -46.03 to 24.182

SecondaryAbsolute 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
Reported as:: Least squares mean · mcg/dL

Absolute Change in Adiponectin
mcg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Adiponectin	0.926 ± 3.605	2.844 ± 2.641

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.660 · Mean difference (final values): -1.918 · 95% CI -10.65 to 6.813

SecondaryAbsolute Change in Total Cholesterol

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Total Cholesterol
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Total Cholesterol	-8.96 ± 57.60	7.77 ± 31.47

SecondaryAbsolute Change in High Density Lipoprotein (HDL) Cholesterol

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in High Density Lipoprotein (HDL) Cholesterol
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in High Density Lipoprotein (HDL) Cholesterol	-0.95 ± 7.94	2.87 ± 7.46

SecondaryAbsolute Change in Low Density Lipoprotein (LDL) Cholesterol

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol	2.39 ± 24.63	6.14 ± 26.74

SecondaryAbsolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol	1.05 ± 12.08	1.54 ± 10.29

SecondaryAbsolute Change in Triglycerides

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Triglycerides
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Triglycerides	-14.71 ± 57.60	-20.97 ± 70.73

SecondaryAbsolute Change in Free Fatty Acids

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Free Fatty Acids
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Free Fatty Acids	-0.03 ± 0.20	-0.05 ± 6.01

SecondaryAbsolute Change in Haemoglobin

Time frame:: Week 0, week 26
Reported as:: Mean · g/dL

Absolute Change in Haemoglobin
g/dL	Insulin Detemir	Insulin NPH
Absolute Change in Haemoglobin	-0.38 ± 0.75	-0.35 ± 0.86

SecondaryAbsolute Change in Blood Volume (Haematocrit)

Time frame:: Week 0, week 26
Reported as:: Mean · percentage

Absolute Change in Blood Volume (Haematocrit)
percentage	Insulin Detemir	Insulin NPH
Absolute Change in Blood Volume (Haematocrit)	-1.17 ± 2.49	-1.06 ± 2.24

SecondaryAbsolute Change in Thrombocytes

Time frame:: Week 0, week 26
Reported as:: Mean · percentage

Absolute Change in Thrombocytes
percentage	Insulin Detemir	Insulin NPH
Absolute Change in Thrombocytes	0.10 ± NA	—

SecondaryAbsolute Change in Erythrocytes

Time frame:: Week 0, week 26
Reported as:: Mean · percentage

Absolute Change in Erythrocytes
percentage	Insulin Detemir	Insulin NPH
Absolute Change in Erythrocytes	4.64 ± 0.58	4.38 ± 0.43

SecondaryAbsolute Change in Leucocytes

Time frame:: Week 0, week 26
Reported as:: Mean · 10^9 cells/L

Absolute Change in Leucocytes
10^9 cells/L	Insulin Detemir	Insulin NPH
Absolute Change in Leucocytes	-0.01 ± 1.68	-0.07 ± 1.17

SecondaryAbsolute Change in Lymphocytes

Time frame:: Week 0, week 26
Reported as:: Mean · percentage

Absolute Change in Lymphocytes
percentage	Insulin Detemir	Insulin NPH
Absolute Change in Lymphocytes	-0.10 ± NA	—

SecondaryAbsolute Change in Monocytes

Time frame:: Week 0, week 26
Reported as:: Mean · percentage

Absolute Change in Monocytes
percentage	Insulin Detemir	Insulin NPH
Absolute Change in Monocytes	0.10 ± NA	—

SecondaryAbsolute Change in Neutrophils

Time frame:: Week 0, week 26
Reported as:: Mean · percentage

Absolute Change in Neutrophils
percentage	Insulin Detemir	Insulin NPH
Absolute Change in Neutrophils	-0.29 ± 1.32	0.01 ± 1.03

SecondaryAbsolute Change in Eosinophils

Time frame:: Week 0, week 26
Reported as:: Mean · 10^9 cells/L

Absolute Change in Eosinophils
10^9 cells/L	Insulin Detemir	Insulin NPH
Absolute Change in Eosinophils	0.01 ± 0.08	0.01 ± 0.09

SecondaryAbsolute Change in Basophils

Time frame:: Week 0, week 26
Reported as:: Mean · 10^9 cells/L

Absolute Change in Basophils
10^9 cells/L	Insulin Detemir	Insulin NPH
Absolute Change in Basophils	0.00 ± 0.10	-0.01 ± 0.05

SecondaryAbsolute Change in Creatinine

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Creatinine
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Creatinine	0.03 ± 0.19	-0.00 ± 0.16

SecondaryAbsolute Change in Creatine Phosphokinase

Time frame:: Week 0, week 26
Reported as:: Mean · IU/L

Absolute Change in Creatine Phosphokinase
IU/L	Insulin Detemir	Insulin NPH
Absolute Change in Creatine Phosphokinase	-19.86 ± 71.49	21.56 ± 50.11

SecondaryAbsolute Change in Urea

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Urea
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Urea	2.45 ± 10.00	0.50 ± 6.75

SecondaryAbsolute Change in Albumin

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Albumin
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Albumin	-0.02 ± 0.40	0.01 ± 0.37

SecondaryAbsolute Change in Bilirubin Total

Time frame:: Week 0, week 26
Reported as:: Mean · mg/dL

Absolute Change in Bilirubin Total
mg/dL	Insulin Detemir	Insulin NPH
Absolute Change in Bilirubin Total	-0.07 ± 0.23	-0.07 ± 0.20

SecondaryAbsolute Change in Alanine Aminotransferase (ALAT)

Time frame:: Week 0, week 26
Reported as:: Mean · IU/L

Absolute Change in Alanine Aminotransferase (ALAT)
IU/L	Insulin Detemir	Insulin NPH
Absolute Change in Alanine Aminotransferase (ALAT)	-3.59 ± 8.43	-4.55 ± 19.68

SecondaryAbsolute Change in Aspartate Aminotransferase (ASAT)

Time frame:: Week 0, week 26
Reported as:: Mean · IU/L

Absolute Change in Aspartate Aminotransferase (ASAT)
IU/L	Insulin Detemir	Insulin NPH
Absolute Change in Aspartate Aminotransferase (ASAT)	0.23 ± 6.91	-0.48 ± 12.87

SecondaryAbsolute Change in Alkaline Phosphatase

Time frame:: Week 0, week 26
Reported as:: Mean · IU/L

Absolute Change in Alkaline Phosphatase
IU/L	Insulin Detemir	Insulin NPH
Absolute Change in Alkaline Phosphatase	-7.10 ± 18.61	-12.55 ± 57.55

SecondaryAbsolute Change in Sodium

Time frame:: Week 0, week 26
Reported as:: Mean · mmol/L

Absolute Change in Sodium
mmol/L	Insulin Detemir	Insulin NPH
Absolute Change in Sodium	1.12 ± 3.81	0.69 ± 6.02

SecondaryAbsolute Change in Potassium

Time frame:: Week 0, week 26
Reported as:: Mean · mmol/L

Absolute Change in Potassium
mmol/L	Insulin Detemir	Insulin NPH
Absolute Change in Potassium	-0.20 ± 0.97	0.21 ± 0.83

SecondaryAbsolute 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
Reported as:: Least squares mean · kg

Absolute Change in Body Weight
kg	Insulin Detemir	Insulin NPH
Absolute Change in Body Weight	1.663 ± 0.779	2.293 ± 0.630

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.518 · Mean difference (final values): -0.629 · 95% CI -2.572 to 1.313

SecondaryAbsolute 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
Reported as:: Least squares mean · cm

Absolute Change in Waist Circumference
cm	Insulin Detemir	Insulin NPH
Absolute Change in Waist Circumference	0.064 ± 1.062	0.609 ± 0.832

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.673 · Mean difference (final values): -0.546 · 95% CI -3.123 to 2.032

SecondaryAbsolute 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
Reported as:: Least squares mean · cm

Absolute Change in Hip Circumference
cm	Insulin Detemir	Insulin NPH
Absolute Change in Hip Circumference	0.577 ± 1.142	0.112 ± 0.905

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.738 · Mean difference (final values): 0.466 · 95% CI -2.319 to 3.250

SecondaryAbsolute 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
Reported as:: Least squares mean · mg/L

Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
mg/L	Insulin Detemir	Insulin NPH
Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)	1.200 ± 1.787	-0.862 ± 1.373

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.346 · Mean difference (final values): 2.062 · 95% CI -2.300 to 6.423

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

Time frame:: Week 0, week 26
Reported as:: Least squares mean · ng/L

Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
ng/L	Insulin Detemir	Insulin NPH
Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)	-10.77 ± 5.119	-12.50 ± 3.765

Statistical analysis

Insulin Detemir vs Insulin NPH · ANCOVA · p = 0.781 · Mean difference (final values): 1.726 · 95% CI -10.71 to 14.167

SecondaryNumber of Hypoglycaemic Episodes

Number of episodes reported during the trial.

Time frame:: Weeks 0-26
Reported as:: Number · episodes

Number of Hypoglycaemic Episodes
episodes	Insulin Detemir	Insulin NPH
Number of Hypoglycaemic Episodes	17	32

SecondaryNumber of Non-serious Adverse Events

Number of episodes reported during the trial.

Time frame:: Weeks 0-26
Reported as:: Number · events

Number of Non-serious Adverse Events
events	Insulin Detemir	Insulin NPH
Number of Non-serious Adverse Events	64	103

Adverse events

Collected over Adverse events were collected in a time span of 26 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Insulin Detemir	—	3/24 (12.5%)	18/24 (75%)
Insulin NPH	—	3/35 (8.6%)	29/35 (82.9%)

Most frequent serious events

Most frequent serious events
Event	Insulin Detemir	Insulin NPH
HypoglycaemiaMetabolism and nutrition disorders	1/24	0/35
Insulin aspart overdoseInjury, poisoning and procedural complications	1/24	1/35
Crushed vertebra D-12Injury, poisoning and procedural complications	1/24	0/35
Ischaemic cardiopathyCardiac disorders	1/24	0/35
White carotid ictusNervous system disorders	0/24	1/35
Vascular ulcer worseningSkin and subcutaneous tissue disorders	0/24	1/35

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Insulin Detemir	Insulin NPH
NasopharyngitisInfections and infestations	7/24	7/35
HeadacheNervous system disorders	4/24	7/35
Back painMusculoskeletal and connective tissue disorders	3/24	4/35
DiarrhoeaGastrointestinal disorders	1/24	4/35
BronchitisInfections and infestations	0/24	3/35
PharyngitisInfections and infestations	0/24	3/35
Ear painEar and labyrinth disorders	2/24	0/35
Abdominal pain, upperGastrointestinal disorders	0/24	2/35
PainGeneral disorders	0/24	2/35
Ear infectionInfections and infestations	0/24	2/35

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Insulin Detemir	Insulin NPH	Total
<=18 years	0	0	0
Between 18 and 65 years	18	18	36
>=65 years	6	17	23

Age, Continuous
Age, Continuous(years)	Insulin Detemir	Insulin NPH	Total
Mean	60.63 ± 8.87	63.74 ± 9.39	62.47 ± 9.24

Sex: Female, Male
Sex: Female, Male(Participants)	Insulin Detemir	Insulin NPH	Total
Female	11	19	30
Male	13	16	29

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Insulin Detemir	Insulin NPH	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	0	0	0
Unknown or Not Reported	24	35	59

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Insulin Detemir	Insulin NPH	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	24	35	59
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Insulin Detemir	Insulin NPH	Total
Spain	24	35	59

Duration of diabetes
Duration of diabetes(years)	Insulin Detemir	Insulin NPH	Total
Mean	13.58 ± 6.68	17.43 ± 9.00	15.86 ± 8.29

Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes)
Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes)(participants)	Insulin Detemir	Insulin NPH	Total
Yes	4	5	9
No	20	30	50

3 further baseline measures are reported on the registry.

Study locations

1 site

Málaga, 29009, Spain

References and documents

Publications

Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4. PubMed 33166419 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00795600
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Nov 21, 2008
Start date: Apr 2009
Primary completion: Aug 2010
Completion: Aug 2010
Results posted: Jun 17, 2013
Last update: Mar 16, 2016

Study contacts

Global Clinical Registry (GCR, 1452)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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

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