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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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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: insulin detemir
Drug: insulin NPH
Enrollment 60
Recruitment Details Recruitment from 29-Apr-2009 until 02-Feb-2010. 5 sites in Spain.
Pre-assignment Details  
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks 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
Period Title: Overall Study
Started 25 35
Exposed to Drug 24 [1] 35
Completed 21 31
Not Completed 4 4
Reason Not Completed
Adverse Event             1             1
Protocol Violation             1             2
Withdrawal by Subject             1             0
Unclassified             1             1
[1]
1 patient did not take study medication because the patient withdrew consent
Arm/Group Title Insulin Detemir Insulin NPH Total
Hide Arm/Group Description Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks 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 Total of all reporting groups
Overall Number of Baseline Participants 24 35 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  75.0%
18
  51.4%
36
  61.0%
>=65 years
6
  25.0%
17
  48.6%
23
  39.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 35 participants 59 participants
60.63  (8.87) 63.74  (9.39) 62.47  (9.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
Female
11
  45.8%
19
  54.3%
30
  50.8%
Male
13
  54.2%
16
  45.7%
29
  49.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
24
 100.0%
35
 100.0%
59
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
24
 100.0%
35
 100.0%
59
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 24 participants 35 participants 59 participants
24 35 59
Duration of diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 35 participants 59 participants
13.58  (6.68) 17.43  (9.00) 15.86  (8.29)
[1]
Measure Description: Number of years since diagnosis
Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
Yes 4 5 9
No 20 30 50
Diabetic complication at baseline, neuropathy (common risk factor in uncontrolled diabetes)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
Yes 5 7 12
No 19 28 47
Diabetic complication at baseline, retinopathy (common risk factor in uncontrolled diabetes)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
Yes 11 16 27
No 13 19 32
Diabetic complication at baseline, macroangiopathy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 35 participants 59 participants
Yes 4 12 16
No 20 23 43
1.Primary Outcome
Title Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.366  (2.785) 1.011  (2.158)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.849
Comments H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.645
Confidence Interval 95%
-7.404 to 6.114
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.364
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.535  (2.875) 1.126  (2.212)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.590
Confidence Interval 95%
-7.588 to 6.407
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.478
Estimation Comments [Not Specified]
3.Primary Outcome
Title Absolute Change in Trunk Fat Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: grams (g)
133.99  (412.88) -62.37  (320.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.696
Comments H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 196.36
Confidence Interval 95%
-805.8 to 1198.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 498.70
Estimation Comments [Not Specified]
4.Primary Outcome
Title Absolute Change in Trunk Fat Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Least Squares Mean (Standard Error)
Unit of Measure: grams (g)
153.38  (423.93) 39.43  (327.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 192.81
Confidence Interval 95%
-844.0 to 1229.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 515.40
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Absolute Change in Whole Body Fat Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: grams (g)
1147.1  (635.79) 858.88  (494.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.709
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 288.21
Confidence Interval 95%
-1252.0 to 1828.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 766.41
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage Change in Whole Body Fat Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.870  (2.267) 4.047  (1.762)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.178
Confidence Interval 95%
-5.668 to 5.313
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.732
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Absolute Change in Whole Body Lean Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: grams (g)
-54.20  (673.32) 1097.2  (524.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1151.0
Confidence Interval 95%
-2780.0 to 477.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 810.48
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage Change in Whole Body Lean Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.051  (1.485) 2.798  (1.158)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.747
Confidence Interval 95%
-6.340 to 0.846
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.788
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Absolute Change in Trunk Lean Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: grams (g)
359.43  (306.47) 469.84  (238.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -110.4
Confidence Interval 95%
-851.3 to 630.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 368.69
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage Change in Trunk Lean Mass
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.480  (1.381) 2.090  (1.076)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.716
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.610
Confidence Interval 95%
-3.949 to 2.729
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.662
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Absolute Change in Calculated Whole Body Fat Percentage
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent of whole body fat (%)
0.782  (0.578) 0.291  (0.450)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.491
Confidence Interval 95%
-0.906 to 1.888
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.695
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentual Change in Calculated Whole Body Fat Percentage
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.607  (1.587) 1.491  (1.235)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.116
Confidence Interval 95%
-3.721 to 3.953
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.909
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Absolute Change in Calculated Trunk Fat Percentage
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent of trunk fat (%)
-0.600  (0.621) -0.321  (0.483)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.711
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.278
Confidence Interval 95%
-1.778 to 1.221
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.746
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentual Change in Calculated Trunk Fat Percentage
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-1.543  (1.542) 0.042  (1.201)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.585
Confidence Interval 95%
-5.310 to 2.141
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.854
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Absolute Change in Visceral Adipose Tissue Area
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: cm^2
-3.258  (9.122) 5.658  (7.042)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.916
Confidence Interval 95%
-30.99 to 13.159
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.985
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage Change in Visceral Adipose Tissue Area
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.535  (5.162) 4.526  (3.4985)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.420
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.061
Confidence Interval 95%
-17.55 to 7.430
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.216
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Absolute Change in Subcutaneous Adipose Tissue Area
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: cm^2
7.654  (10.764) 12.616  (8.375)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.961
Confidence Interval 95%
-31.10 to 21.178
Parameter Dispersion
Type: Standard Error of the mean
Value: 13.007
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage Change in Subcutaneous Adipose Tissue Area
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.153  (3.952) 5.743  (3.075)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.590
Confidence Interval 95%
-14.19 to 5.007
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.776
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.032  (0.028) -0.036  (0.022)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.902
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.004
Confidence Interval 95%
-0.064 to 0.073
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.034
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.092  (3.211) -3.303  (2.493)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.839
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.789
Confidence Interval 95%
-8.525 to 6.947
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.850
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Absolute Change in Liver/Spleen Attenuation Ratio
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.044  (0.035) -0.023  (0.026)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.021
Confidence Interval 95%
-0.105 to 0.062
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.041
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage Change in Liver/Spleen Attenuation Ratio
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.632  (3.102) -0.855  (2.355)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.777
Confidence Interval 95%
-9.254 to 5.700
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.719
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Absolute Change in HbA1c (Glycosylated Haemoglobin)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated haemoglobin
-0.922  (0.226) -0.792  (0.172)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.130
Confidence Interval 95%
-0.663 to 0.403
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.266
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Absolute Change in Fasting Plasma Glucose (FPG)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 29
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-48.29  (14.599) -37.36  (11.616)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.92
Confidence Interval 95%
-46.03 to 24.182
Parameter Dispersion
Type: Standard Error of the mean
Value: 17.460
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Absolute Change in Adiponectin
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 18 31
Least Squares Mean (Standard Error)
Unit of Measure: mcg/dL
0.926  (3.605) 2.844  (2.641)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.918
Confidence Interval 95%
-10.65 to 6.813
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.332
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Absolute Change in Total Cholesterol
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
-8.96  (57.60) 7.77  (31.47)
27.Secondary Outcome
Title Absolute Change in High Density Lipoprotein (HDL) Cholesterol
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.95  (7.94) 2.87  (7.46)
28.Secondary Outcome
Title Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.39  (24.63) 6.14  (26.74)
29.Secondary Outcome
Title Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 28
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.05  (12.08) 1.54  (10.29)
30.Secondary Outcome
Title Absolute Change in Triglycerides
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 29
Mean (Standard Deviation)
Unit of Measure: mg/dL
-14.71  (57.60) -20.97  (70.73)
31.Secondary Outcome
Title Absolute Change in Free Fatty Acids
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.03  (0.20) -0.05  (6.01)
32.Secondary Outcome
Title Absolute Change in Haemoglobin
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.38  (0.75) -0.35  (0.86)
33.Secondary Outcome
Title Absolute Change in Blood Volume (Haematocrit)
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Mean (Standard Deviation)
Unit of Measure: percentage
-1.17  (2.49) -1.06  (2.24)
34.Secondary Outcome
Title Absolute Change in Thrombocytes
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: percentage
0.10 [1]   (NA)
[1]
No standard deviation calculated due to lack of available values at week 26
35.Secondary Outcome
Title Absolute Change in Erythrocytes
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Mean (Standard Deviation)
Unit of Measure: percentage
4.64  (0.58) 4.38  (0.43)
36.Secondary Outcome
Title Absolute Change in Leucocytes
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
-0.01  (1.68) -0.07  (1.17)
37.Secondary Outcome
Title Absolute Change in Lymphocytes
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: percentage
-0.10 [1]   (NA)
[1]
No standard deviation calculated due to lack of available values at week 26
38.Secondary Outcome
Title Absolute Change in Monocytes
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: percentage
0.10 [1]   (NA)
[1]
No standard deviation calculated due to lack of available values at week 26
39.Secondary Outcome
Title Absolute Change in Neutrophils
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: percentage
-0.29  (1.32) 0.01  (1.03)
40.Secondary Outcome
Title Absolute Change in Eosinophils
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
0.01  (0.08) 0.01  (0.09)
41.Secondary Outcome
Title Absolute Change in Basophils
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 9 22
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
0.00  (0.10) -0.01  (0.05)
42.Secondary Outcome
Title Absolute Change in Creatinine
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatinine at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.03  (0.19) -0.00  (0.16)
43.Secondary Outcome
Title Absolute Change in Creatine Phosphokinase
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatine Phosphokinase at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Mean (Standard Deviation)
Unit of Measure: IU/L
-19.86  (71.49) 21.56  (50.11)
44.Secondary Outcome
Title Absolute Change in Urea
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.45  (10.00) 0.50  (6.75)
45.Secondary Outcome
Title Absolute Change in Albumin
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 20 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.02  (0.40) 0.01  (0.37)
46.Secondary Outcome
Title Absolute Change in Bilirubin Total
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.07  (0.23) -0.07  (0.20)
47.Secondary Outcome
Title Absolute Change in Alanine Aminotransferase (ALAT)
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Mean (Standard Deviation)
Unit of Measure: IU/L
-3.59  (8.43) -4.55  (19.68)
48.Secondary Outcome
Title Absolute Change in Aspartate Aminotransferase (ASAT)
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 31
Mean (Standard Deviation)
Unit of Measure: IU/L
0.23  (6.91) -0.48  (12.87)
49.Secondary Outcome
Title Absolute Change in Alkaline Phosphatase
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Mean (Standard Deviation)
Unit of Measure: IU/L
-7.10  (18.61) -12.55  (57.55)
50.Secondary Outcome
Title Absolute Change in Sodium
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 22 32
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.12  (3.81) 0.69  (6.02)
51.Secondary Outcome
Title Absolute Change in Potassium
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 32
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.20  (0.97) 0.21  (0.83)
52.Secondary Outcome
Title Absolute Change in Body Weight
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 23 32
Least Squares Mean (Standard Error)
Unit of Measure: kg
1.663  (0.779) 2.293  (0.630)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.518
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.629
Confidence Interval 95%
-2.572 to 1.313
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.967
Estimation Comments [Not Specified]
53.Secondary Outcome
Title Absolute Change in Waist Circumference
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 23 32
Least Squares Mean (Standard Error)
Unit of Measure: cm
0.064  (1.062) 0.609  (0.832)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.546
Confidence Interval 95%
-3.123 to 2.032
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.283
Estimation Comments [Not Specified]
54.Secondary Outcome
Title Absolute Change in Hip Circumference
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 23 32
Least Squares Mean (Standard Error)
Unit of Measure: cm
0.577  (1.142) 0.112  (0.905)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.466
Confidence Interval 95%
-2.319 to 3.250
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.386
Estimation Comments [Not Specified]
55.Secondary Outcome
Title Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 21 31
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
1.200  (1.787) -0.862  (1.373)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.062
Confidence Interval 95%
-2.300 to 6.423
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.168
Estimation Comments [Not Specified]
56.Secondary Outcome
Title Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
Hide Description [Not Specified]
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 18 31
Least Squares Mean (Standard Error)
Unit of Measure: ng/L
-10.77  (5.119) -12.50  (3.765)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Detemir, Insulin NPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.726
Confidence Interval 95%
-10.71 to 14.167
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.173
Estimation Comments [Not Specified]
57.Secondary Outcome
Title Number of Hypoglycaemic Episodes
Hide Description Number of episodes reported during the trial.
Time Frame Weeks 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 24 35
Measure Type: Number
Unit of Measure: episodes
17 32
58.Secondary Outcome
Title Number of Non-serious Adverse Events
Hide Description Number of episodes reported during the trial.
Time Frame Weeks 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description:
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
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
Overall Number of Participants Analyzed 24 35
Measure Type: Number
Unit of Measure: events
64 103
Time Frame Adverse events were collected in a time span of 26 weeks.
Adverse Event Reporting Description Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
 
Arm/Group Title Insulin Detemir Insulin NPH
Hide Arm/Group Description Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks 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
All-Cause Mortality
Insulin Detemir Insulin NPH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Detemir Insulin NPH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/24 (12.50%)      3/35 (8.57%)    
Cardiac disorders     
Ischaemic cardiopathy  1  1/24 (4.17%)  1 0/35 (0.00%)  0
Injury, poisoning and procedural complications     
Insulin aspart overdose  1  1/24 (4.17%)  1 1/35 (2.86%)  1
Crushed vertebra D-12  1  1/24 (4.17%)  1 0/35 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/24 (4.17%)  1 0/35 (0.00%)  0
Nervous system disorders     
White carotid ictus  1  0/24 (0.00%)  0 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders     
Vascular ulcer worsening  1  0/24 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Insulin Detemir Insulin NPH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/24 (75.00%)      29/35 (82.86%)    
Ear and labyrinth disorders     
Ear pain  1  2/24 (8.33%)  2 0/35 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain, upper  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Diarrhoea  1  1/24 (4.17%)  1 4/35 (11.43%)  4
General disorders     
Pain  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Infections and infestations     
Bronchitis  1  0/24 (0.00%)  0 3/35 (8.57%)  4
Ear infection  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Nasopharyngitis  1  7/24 (29.17%)  11 7/35 (20.00%)  9
Pharyngitis  1  0/24 (0.00%)  0 3/35 (8.57%)  3
Vulvovaginal candidiasis  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/24 (4.17%)  1 2/35 (5.71%)  3
Back pain  1  3/24 (12.50%)  5 4/35 (11.43%)  10
Musculoskeletal pain  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Pain in extremity  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Nervous system disorders     
Headache  1  4/24 (16.67%)  5 7/35 (20.00%)  7
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Vascular disorders     
Hypertension  1  0/24 (0.00%)  0 2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
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Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00795600     History of Changes
Other Study ID Numbers: NN304-3614
2008-003739-19 ( EudraCT Number )
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: August 9, 2011
Results First Posted: June 17, 2013
Last Update Posted: March 16, 2016