Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
Interventions
DRUGinsulin detemir
Insulin detemir once daily plus insulin aspart at mealtime
DRUGinsulin NPH
Insulin NPH once daily plus insulin aspart at mealtime
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) | week 0, week 26 | Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor. |
| Absolute Change in Trunk Fat Mass | week 0, week 26 | Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Whole Body Lean Mass | Week 0, week 26 | Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate. |
| Percentage Change in Whole Body Lean Mass | Week 0, week 26 | Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate. |
| Absolute Change in Trunk Lean Mass | Week 0, week 26 | Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate |
| Percentage Change in Trunk Lean Mass | Week 0, week 26 | Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate. |
| Absolute Change in Calculated Whole Body Fat Percentage | Week 0, week 26 | Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate |
| Percentual Change in Calculated Whole Body Fat Percentage | Week 0, week 26 | Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate. |
| Absolute Change in Calculated Trunk Fat Percentage | Week 0, week 26 | Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate |
| Percentual Change in Calculated Trunk Fat Percentage | Week 0, week 26 | Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate. |
| Absolute Change in Visceral Adipose Tissue Area | Week 0, week 26 | Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate |
| Percentage Change in Visceral Adipose Tissue Area | Week 0, week 26 | Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate. |
| Absolute Change in Subcutaneous Adipose Tissue Area | Week 0, week 26 | Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate |
| Percentage Change in Subcutaneous Adipose Tissue Area | Week 0, week 26 | Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate. |
| Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | Week 0, week 26 | Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. |
| Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | Week 0, week 26 | Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. |
| Absolute Change in Liver/Spleen Attenuation Ratio | Week 0, week 26 | Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate. |
| Percentage Change in Liver/Spleen Attenuation Ratio | Week 0, week 26 | Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate. |
| Absolute Change in HbA1c (Glycosylated Haemoglobin) | Week 0, week 26 | Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate. |
| Absolute Change in Fasting Plasma Glucose (FPG) | Week 0, week 26 | Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate. |
| Absolute Change in Adiponectin | Week 0, week 26 | Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate. |
| Absolute Change in Total Cholesterol | Week 0, week 26 | — |
| Absolute Change in High Density Lipoprotein (HDL) Cholesterol | Week 0, week 26 | — |
| Absolute Change in Low Density Lipoprotein (LDL) Cholesterol | Week 0, week 26 | — |
| Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol | Week 0, week 26 | — |
| Absolute Change in Triglycerides | Week 0, week 26 | — |
| Absolute Change in Free Fatty Acids | Week 0, week 26 | — |
| Absolute Change in Haemoglobin | Week 0, week 26 | — |
| Absolute Change in Blood Volume (Haematocrit) | Week 0, week 26 | — |
| Absolute Change in Thrombocytes | Week 0, week 26 | — |
| Absolute Change in Erythrocytes | Week 0, week 26 | — |
| Absolute Change in Leucocytes | Week 0, week 26 | — |
| Absolute Change in Lymphocytes | Week 0, week 26 | — |
| Absolute Change in Monocytes | Week 0, week 26 | — |
| Absolute Change in Neutrophils | Week 0, week 26 | — |
| Absolute Change in Eosinophils | Week 0, week 26 | — |
| Absolute Change in Basophils | Week 0, week 26 | — |
| Absolute Change in Creatinine | Week 0, week 26 | — |
| Absolute Change in Creatine Phosphokinase | Week 0, week 26 | — |
| Absolute Change in Urea | Week 0, week 26 | — |
| Absolute Change in Albumin | Week 0, week 26 | — |
| Absolute Change in Bilirubin Total | Week 0, week 26 | — |
| Absolute Change in Alanine Aminotransferase (ALAT) | Week 0, week 26 | — |
| Absolute Change in Aspartate Aminotransferase (ASAT) | Week 0, week 26 | — |
| Absolute Change in Alkaline Phosphatase | Week 0, week 26 | — |
| Absolute Change in Sodium | Week 0, week 26 | — |
| Absolute Change in Potassium | Week 0, week 26 | — |
| Absolute Change in Body Weight | Week 0, week 26 | Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable. |
| Absolute Change in Whole Body Fat Mass | Week 0, week 26 | Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. |
| Absolute Change in Hip Circumference | Week 0, week 26 | Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate. |
| Absolute Change in hsCRP (Highly Sensitive C Reactive Protein) | Week 0, week 26 | Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate. |
| Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) | Week 0, week 26 | — |
| Number of Hypoglycaemic Episodes | Weeks 0-26 | Number of episodes reported during the trial. |
| Number of Non-serious Adverse Events | Weeks 0-26 | Number of episodes reported during the trial. |
| Absolute Change in Waist Circumference | Week 0, week 26 | Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate. |
| Percentage Change in Whole Body Fat Mass | Week 0, week 26 | Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate. |
Countries
Spain
Participant flow
Recruitment details
Recruitment from 29-Apr-2009 until 02-Feb-2010. 5 sites in Spain.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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 | 35 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Unclassified | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Insulin Detemir | Insulin NPH | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 17 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Continuous | 60.63 years STANDARD_DEVIATION 8.87 | 63.74 years STANDARD_DEVIATION 9.39 | 62.47 years STANDARD_DEVIATION 9.24 |
| Diabetic complication at baseline, macroangiopathy No | 20 participants | 23 participants | 43 participants |
| Diabetic complication at baseline, macroangiopathy Yes | 4 participants | 12 participants | 16 participants |
| Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes) No | 20 participants | 30 participants | 50 participants |
| Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes) Yes | 4 participants | 5 participants | 9 participants |
| Diabetic complication at baseline, neuropathy (common risk factor in uncontrolled diabetes) No | 19 participants | 28 participants | 47 participants |
| Diabetic complication at baseline, neuropathy (common risk factor in uncontrolled diabetes) Yes | 5 participants | 7 participants | 12 participants |
| Diabetic complication at baseline, retinopathy (common risk factor in uncontrolled diabetes) No | 13 participants | 19 participants | 32 participants |
| Diabetic complication at baseline, retinopathy (common risk factor in uncontrolled diabetes) Yes | 11 participants | 16 participants | 27 participants |
| Duration of diabetes | 13.58 years STANDARD_DEVIATION 6.68 | 17.43 years STANDARD_DEVIATION 9 | 15.86 years STANDARD_DEVIATION 8.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants | 35 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 35 Participants | 59 Participants |
| Region of Enrollment Spain | 24 participants | 35 participants | 59 participants |
| Sex: Female, Male Female | 11 Participants | 19 Participants | 30 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 24 | 29 / 35 |
| serious Total, serious adverse events | 3 / 24 | 3 / 35 |
Outcome results
Primary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Trunk Fat Mass | 133.99 grams (g) | Standard Error 412.88 |
| Insulin NPH | Absolute Change in Trunk Fat Mass | -62.37 grams (g) | Standard Error 320 |
Comparison: 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.p-value: 0.69695% CI: [-805.8, 1198.5]ANCOVA
Primary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Trunk Fat Mass | 153.38 grams (g) | Standard Error 423.93 |
| Insulin NPH | Absolute Change in Trunk Fat Mass | 39.43 grams (g) | Standard Error 327.78 |
Comparison: 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.p-value: 0.7195% CI: [-844, 1229.7]ANCOVA
Primary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) | 0.366 percent change | Standard Error 2.785 |
| Insulin NPH | Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) | 1.011 percent change | Standard Error 2.158 |
Comparison: 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.p-value: 0.84995% CI: [-7.404, 6.114]ANCOVA
Primary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) | 0.535 percent change | Standard Error 2.875 |
| Insulin NPH | Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) | 1.126 percent change | Standard Error 2.212 |
Comparison: 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.p-value: 0.94895% CI: [-7.588, 6.407]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Adiponectin | 0.926 mcg/dL | Standard Error 3.605 |
| Insulin NPH | Absolute Change in Adiponectin | 2.844 mcg/dL | Standard Error 2.641 |
p-value: 0.6695% CI: [-10.65, 6.813]ANCOVA
Secondary
Absolute Change in Alanine Aminotransferase (ALAT)
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Alanine Aminotransferase (ALAT) | -3.59 IU/L | Standard Deviation 8.43 |
| Insulin NPH | Absolute Change in Alanine Aminotransferase (ALAT) | -4.55 IU/L | Standard Deviation 19.68 |
Secondary
Absolute Change in Albumin
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Albumin | -0.02 mg/dL | Standard Deviation 0.4 |
| Insulin NPH | Absolute Change in Albumin | 0.01 mg/dL | Standard Deviation 0.37 |
Secondary
Absolute Change in Alkaline Phosphatase
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Alkaline Phosphatase | -7.10 IU/L | Standard Deviation 18.61 |
| Insulin NPH | Absolute Change in Alkaline Phosphatase | -12.55 IU/L | Standard Deviation 57.55 |
Secondary
Absolute Change in Aspartate Aminotransferase (ASAT)
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Aspartate Aminotransferase (ASAT) | 0.23 IU/L | Standard Deviation 6.91 |
| Insulin NPH | Absolute Change in Aspartate Aminotransferase (ASAT) | -0.48 IU/L | Standard Deviation 12.87 |
Secondary
Absolute Change in Basophils
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Basophils | 0.00 10^9 cells/L | Standard Deviation 0.1 |
| Insulin NPH | Absolute Change in Basophils | -0.01 10^9 cells/L | Standard Deviation 0.05 |
Secondary
Absolute Change in Bilirubin Total
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Bilirubin Total | -0.07 mg/dL | Standard Deviation 0.23 |
| Insulin NPH | Absolute Change in Bilirubin Total | -0.07 mg/dL | Standard Deviation 0.2 |
Secondary
Absolute Change in Blood Volume (Haematocrit)
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Blood Volume (Haematocrit) | -1.17 percentage | Standard Deviation 2.49 |
| Insulin NPH | Absolute Change in Blood Volume (Haematocrit) | -1.06 percentage | Standard Deviation 2.24 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Body Weight | 1.663 kg | Standard Error 0.779 |
| Insulin NPH | Absolute Change in Body Weight | 2.293 kg | Standard Error 0.63 |
p-value: 0.51895% CI: [-2.572, 1.313]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Calculated Trunk Fat Percentage | -0.600 percent of trunk fat (%) | Standard Error 0.621 |
| Insulin NPH | Absolute Change in Calculated Trunk Fat Percentage | -0.321 percent of trunk fat (%) | Standard Error 0.483 |
p-value: 0.71195% CI: [-1.778, 1.221]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | -0.032 ratio | Standard Error 0.028 |
| Insulin NPH | Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | -0.036 ratio | Standard Error 0.022 |
p-value: 0.90295% CI: [-0.064, 0.073]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Calculated Whole Body Fat Percentage | 0.782 percent of whole body fat (%) | Standard Error 0.578 |
| Insulin NPH | Absolute Change in Calculated Whole Body Fat Percentage | 0.291 percent of whole body fat (%) | Standard Error 0.45 |
p-value: 0.48395% CI: [-0.906, 1.888]ANCOVA
Secondary
Absolute Change in Creatine Phosphokinase
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Creatine Phosphokinase | -19.86 IU/L | Standard Deviation 71.49 |
| Insulin NPH | Absolute Change in Creatine Phosphokinase | 21.56 IU/L | Standard Deviation 50.11 |
Secondary
Absolute Change in Creatinine
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Creatinine | 0.03 mg/dL | Standard Deviation 0.19 |
| Insulin NPH | Absolute Change in Creatinine | -0.00 mg/dL | Standard Deviation 0.16 |
Secondary
Absolute Change in Eosinophils
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Eosinophils | 0.01 10^9 cells/L | Standard Deviation 0.08 |
| Insulin NPH | Absolute Change in Eosinophils | 0.01 10^9 cells/L | Standard Deviation 0.09 |
Secondary
Absolute Change in Erythrocytes
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Erythrocytes | 4.64 percentage | Standard Deviation 0.58 |
| Insulin NPH | Absolute Change in Erythrocytes | 4.38 percentage | Standard Deviation 0.43 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Fasting Plasma Glucose (FPG) | -48.29 mg/dL | Standard Error 14.599 |
| Insulin NPH | Absolute Change in Fasting Plasma Glucose (FPG) | -37.36 mg/dL | Standard Error 11.616 |
p-value: 0.53595% CI: [-46.03, 24.182]ANCOVA
Secondary
Absolute Change in Free Fatty Acids
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Free Fatty Acids | -0.03 mg/dL | Standard Deviation 0.2 |
| Insulin NPH | Absolute Change in Free Fatty Acids | -0.05 mg/dL | Standard Deviation 6.01 |
Secondary
Absolute Change in Haemoglobin
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Haemoglobin | -0.38 g/dL | Standard Deviation 0.75 |
| Insulin NPH | Absolute Change in Haemoglobin | -0.35 g/dL | Standard Deviation 0.86 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in HbA1c (Glycosylated Haemoglobin) | -0.922 percentage of glycosylated haemoglobin | Standard Error 0.226 |
| Insulin NPH | Absolute Change in HbA1c (Glycosylated Haemoglobin) | -0.792 percentage of glycosylated haemoglobin | Standard Error 0.172 |
p-value: 0.62895% CI: [-0.663, 0.403]ANCOVA
Secondary
Absolute Change in High Density Lipoprotein (HDL) Cholesterol
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in High Density Lipoprotein (HDL) Cholesterol | -0.95 mg/dL | Standard Deviation 7.94 |
| Insulin NPH | Absolute Change in High Density Lipoprotein (HDL) Cholesterol | 2.87 mg/dL | Standard Deviation 7.46 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Hip Circumference | 0.577 cm | Standard Error 1.142 |
| Insulin NPH | Absolute Change in Hip Circumference | 0.112 cm | Standard Error 0.905 |
p-value: 0.73895% CI: [-2.319, 3.25]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in hsCRP (Highly Sensitive C Reactive Protein) | 1.200 mg/L | Standard Error 1.787 |
| Insulin NPH | Absolute Change in hsCRP (Highly Sensitive C Reactive Protein) | -0.862 mg/L | Standard Error 1.373 |
p-value: 0.34695% CI: [-2.3, 6.423]ANCOVA
Secondary
Absolute Change in Leucocytes
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Leucocytes | -0.01 10^9 cells/L | Standard Deviation 1.68 |
| Insulin NPH | Absolute Change in Leucocytes | -0.07 10^9 cells/L | Standard Deviation 1.17 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Liver/Spleen Attenuation Ratio | -0.044 ratio | Standard Error 0.035 |
| Insulin NPH | Absolute Change in Liver/Spleen Attenuation Ratio | -0.023 ratio | Standard Error 0.026 |
p-value: 0.60795% CI: [-0.105, 0.062]ANCOVA
Secondary
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Low Density Lipoprotein (LDL) Cholesterol | 2.39 mg/dL | Standard Deviation 24.63 |
| Insulin NPH | Absolute Change in Low Density Lipoprotein (LDL) Cholesterol | 6.14 mg/dL | Standard Deviation 26.74 |
Secondary
Absolute Change in Lymphocytes
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Insulin Detemir | Absolute Change in Lymphocytes | -0.10 percentage |
Secondary
Absolute Change in Monocytes
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Insulin Detemir | Absolute Change in Monocytes | 0.10 percentage |
Secondary
Absolute Change in Neutrophils
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Neutrophils | -0.29 percentage | Standard Deviation 1.32 |
| Insulin NPH | Absolute Change in Neutrophils | 0.01 percentage | Standard Deviation 1.03 |
Secondary
Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
Time frame: Week 0, week 26
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) | -10.77 ng/L | Standard Error 5.119 |
| Insulin NPH | Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) | -12.50 ng/L | Standard Error 3.765 |
p-value: 0.78195% CI: [-10.71, 14.167]ANCOVA
Secondary
Absolute Change in Potassium
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Potassium | -0.20 mmol/L | Standard Deviation 0.97 |
| Insulin NPH | Absolute Change in Potassium | 0.21 mmol/L | Standard Deviation 0.83 |
Secondary
Absolute Change in Sodium
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Sodium | 1.12 mmol/L | Standard Deviation 3.81 |
| Insulin NPH | Absolute Change in Sodium | 0.69 mmol/L | Standard Deviation 6.02 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Subcutaneous Adipose Tissue Area | 7.654 cm^2 | Standard Error 10.764 |
| Insulin NPH | Absolute Change in Subcutaneous Adipose Tissue Area | 12.616 cm^2 | Standard Error 8.375 |
p-value: 0.70595% CI: [-31.1, 21.178]ANCOVA
Secondary
Absolute Change in Thrombocytes
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Insulin Detemir | Absolute Change in Thrombocytes | 0.10 percentage |
Secondary
Absolute Change in Total Cholesterol
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Total Cholesterol | -8.96 mg/dL | Standard Deviation 57.6 |
| Insulin NPH | Absolute Change in Total Cholesterol | 7.77 mg/dL | Standard Deviation 31.47 |
Secondary
Absolute Change in Triglycerides
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Triglycerides | -14.71 mg/dL | Standard Deviation 57.6 |
| Insulin NPH | Absolute Change in Triglycerides | -20.97 mg/dL | Standard Deviation 70.73 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Trunk Lean Mass | 359.43 grams (g) | Standard Error 306.47 |
| Insulin NPH | Absolute Change in Trunk Lean Mass | 469.84 grams (g) | Standard Error 238.67 |
p-value: 0.76695% CI: [-851.3, 630.51]ANCOVA
Secondary
Absolute Change in Urea
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Urea | 2.45 mg/dL | Standard Deviation 10 |
| Insulin NPH | Absolute Change in Urea | 0.50 mg/dL | Standard Deviation 6.75 |
Secondary
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame: Week 0, week 26
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol | 1.05 mg/dL | Standard Deviation 12.08 |
| Insulin NPH | Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol | 1.54 mg/dL | Standard Deviation 10.29 |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Visceral Adipose Tissue Area | -3.258 cm^2 | Standard Error 9.122 |
| Insulin NPH | Absolute Change in Visceral Adipose Tissue Area | 5.658 cm^2 | Standard Error 7.042 |
p-value: 0.42195% CI: [-30.99, 13.159]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Waist Circumference | 0.064 cm | Standard Error 1.062 |
| Insulin NPH | Absolute Change in Waist Circumference | 0.609 cm | Standard Error 0.832 |
p-value: 0.67395% CI: [-3.123, 2.032]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Whole Body Fat Mass | 1147.1 grams (g) | Standard Error 635.79 |
| Insulin NPH | Absolute Change in Whole Body Fat Mass | 858.88 grams (g) | Standard Error 494.14 |
p-value: 0.70995% CI: [-1252, 1828.4]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Absolute Change in Whole Body Lean Mass | -54.20 grams (g) | Standard Error 673.32 |
| Insulin NPH | Absolute Change in Whole Body Lean Mass | 1097.2 grams (g) | Standard Error 524.74 |
p-value: 0.16295% CI: [-2780, 477.33]ANCOVA
Secondary
Number of Hypoglycaemic Episodes
Number of episodes reported during the trial.
Time frame: Weeks 0-26
Population: Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir | Number of Hypoglycaemic Episodes | 17 episodes |
| Insulin NPH | Number of Hypoglycaemic Episodes | 32 episodes |
Secondary
Number of Non-serious Adverse Events
Number of episodes reported during the trial.
Time frame: Weeks 0-26
Population: Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir | Number of Non-serious Adverse Events | 64 events |
| Insulin NPH | Number of Non-serious Adverse Events | 103 events |
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | -4.092 percent change | Standard Error 3.211 |
| Insulin NPH | Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | -3.303 percent change | Standard Error 2.493 |
p-value: 0.83995% CI: [-8.525, 6.947]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Liver/Spleen Attenuation Ratio | -2.632 percent change | Standard Error 3.102 |
| Insulin NPH | Percentage Change in Liver/Spleen Attenuation Ratio | -0.855 percent change | Standard Error 2.355 |
p-value: 0.63595% CI: [-9.254, 5.7]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Subcutaneous Adipose Tissue Area | 1.153 percent change | Standard Error 3.952 |
| Insulin NPH | Percentage Change in Subcutaneous Adipose Tissue Area | 5.743 percent change | Standard Error 3.075 |
p-value: 0.34195% CI: [-14.19, 5.007]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Trunk Lean Mass | 1.480 percent change | Standard Error 1.381 |
| Insulin NPH | Percentage Change in Trunk Lean Mass | 2.090 percent change | Standard Error 1.076 |
p-value: 0.71695% CI: [-3.949, 2.729]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Visceral Adipose Tissue Area | -0.535 percent change | Standard Error 5.162 |
| Insulin NPH | Percentage Change in Visceral Adipose Tissue Area | 4.526 percent change | Standard Error 3.4985 |
p-value: 0.4295% CI: [-17.55, 7.43]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Whole Body Fat Mass | 3.870 percent change | Standard Error 2.267 |
| Insulin NPH | Percentage Change in Whole Body Fat Mass | 4.047 percent change | Standard Error 1.762 |
p-value: 0.94895% CI: [-5.668, 5.313]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentage Change in Whole Body Lean Mass | 0.051 percent change | Standard Error 1.485 |
| Insulin NPH | Percentage Change in Whole Body Lean Mass | 2.798 percent change | Standard Error 1.158 |
p-value: 0.13195% CI: [-6.34, 0.846]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentual Change in Calculated Trunk Fat Percentage | -1.543 percent change | Standard Error 1.542 |
| Insulin NPH | Percentual Change in Calculated Trunk Fat Percentage | 0.042 percent change | Standard Error 1.201 |
p-value: 0.39795% CI: [-5.31, 2.141]ANCOVA
Secondary
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Percentual Change in Calculated Whole Body Fat Percentage | 1.607 percent change | Standard Error 1.587 |
| Insulin NPH | Percentual Change in Calculated Whole Body Fat Percentage | 1.491 percent change | Standard Error 1.235 |
p-value: 0.95295% CI: [-3.721, 3.953]ANCOVA