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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003739-19 | EudraCT Number |
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This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin detemir | Experimental | Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks |
|
| insulin NPH | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Insulin detemir once daily plus insulin aspart at mealtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 0, week 26 |
| Absolute Change in Trunk Fat Mass | Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate. | week 0, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, week 26 |
| Percentage Change in Whole Body Fat Mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Málaga | 29009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33166419 | Derived | Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Recruitment from 29-Apr-2009 until 02-Feb-2010. 5 sites in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Insulin NPH |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | week 0, week 26 |
|
Adverse events were collected in a time span of 26 weeks.
Safety analysis set is all randomised subjects exposed to at least one dose of trial drug(s).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin NPH |
| Drug |
Insulin NPH once daily plus insulin aspart at mealtime |
|
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. |
| Week 0, week 26 |
| Absolute Change in Whole Body Lean Mass | Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate. | Week 0, week 26 |
| Percentage Change in Whole Body Lean Mass | Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Trunk Lean Mass | Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate | Week 0, week 26 |
| Percentage Change in Trunk Lean Mass | Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Calculated Whole Body Fat Percentage | Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate | Week 0, week 26 |
| Percentual Change in Calculated Whole Body Fat Percentage | Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Calculated Trunk Fat Percentage | Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate | Week 0, week 26 |
| Percentual Change in Calculated Trunk Fat Percentage | Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Visceral Adipose Tissue Area | Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate | Week 0, week 26 |
| Percentage Change in Visceral Adipose Tissue Area | Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Subcutaneous Adipose Tissue Area | Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate | Week 0, week 26 |
| Percentage Change in Subcutaneous Adipose Tissue Area | Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. | Week 0, week 26 |
| Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio | Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Liver/Spleen Attenuation Ratio | Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate. | Week 0, week 26 |
| Percentage Change in Liver/Spleen Attenuation Ratio | Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in HbA1c (Glycosylated Haemoglobin) | Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Fasting Plasma Glucose (FPG) | Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Adiponectin | Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate. | Week 0, week 26 |
| 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 | 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. | Week 0, week 26 |
| Absolute Change in Waist Circumference | Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in Hip Circumference | Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in hsCRP (Highly Sensitive C Reactive Protein) | Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate. | Week 0, week 26 |
| Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) | Week 0, week 26 |
| Number of Hypoglycaemic Episodes | Number of episodes reported during the trial. | Weeks 0-26 |
| Number of Non-serious Adverse Events | Number of episodes reported during the trial. | Weeks 0-26 |
| Withdrawal by Subject |
|
| Unclassified |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of diabetes | Number of years since diagnosis | Mean | Standard Deviation | years |
|
| Diabetic complication at baseline, nephropathy (common risk factor in uncontrolled diabetes) | Number | participants |
|
| Diabetic complication at baseline, neuropathy (common risk factor in uncontrolled diabetes) | Number | participants |
|
| Diabetic complication at baseline, retinopathy (common risk factor in uncontrolled diabetes) | Number | participants |
|
| Diabetic complication at baseline, macroangiopathy | Number | participants |
|
| OG001 | 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 |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | week 0, week 26 |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | grams (g) | week 0, week 26 |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | grams (g) | week 0, week 26 |
|
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | grams (g) | Week 0, week 26 |
|
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|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
|
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|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | grams (g) | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | grams (g) | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | percent of whole body fat (%) | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | percent of trunk fat (%) | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | cm^2 | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | cm^2 | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | ratio | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | ratio | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percent change | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mg/dL | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mcg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Total Cholesterol | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in High Density Lipoprotein (HDL) Cholesterol | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Low Density Lipoprotein (LDL) Cholesterol | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Triglycerides | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Free Fatty Acids | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Haemoglobin | 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. | Posted | Mean | Standard Deviation | g/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Blood Volume (Haematocrit) | 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. | Posted | Mean | Standard Deviation | percentage | Week 0, week 26 |
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| Secondary | Absolute Change in Thrombocytes | 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. | Posted | Mean | Standard Deviation | percentage | Week 0, week 26 |
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| Secondary | Absolute Change in Erythrocytes | 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. | Posted | Mean | Standard Deviation | percentage | Week 0, week 26 |
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| Secondary | Absolute Change in Leucocytes | 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. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 0, week 26 |
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| Secondary | Absolute Change in Lymphocytes | 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. | Posted | Mean | Standard Deviation | percentage | Week 0, week 26 |
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| Secondary | Absolute Change in Monocytes | 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. | Posted | Mean | Standard Deviation | percentage | Week 0, week 26 |
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| Secondary | Absolute Change in Neutrophils | 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. | Posted | Mean | Standard Deviation | percentage | Week 0, week 26 |
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| Secondary | Absolute Change in Eosinophils | 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. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 0, week 26 |
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| Secondary | Absolute Change in Basophils | 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. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 0, week 26 |
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| Secondary | Absolute Change in Creatinine | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Creatine Phosphokinase | 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. | Posted | Mean | Standard Deviation | IU/L | Week 0, week 26 |
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| Secondary | Absolute Change in Urea | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Albumin | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Bilirubin Total | 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0, week 26 |
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| Secondary | Absolute Change in Alanine Aminotransferase (ALAT) | 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. | Posted | Mean | Standard Deviation | IU/L | Week 0, week 26 |
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| Secondary | Absolute Change in Aspartate Aminotransferase (ASAT) | 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. | Posted | Mean | Standard Deviation | IU/L | Week 0, week 26 |
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| Secondary | Absolute Change in Alkaline Phosphatase | 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. | Posted | Mean | Standard Deviation | IU/L | Week 0, week 26 |
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| Secondary | Absolute Change in Sodium | 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. | Posted | Mean | Standard Deviation | mmol/L | Week 0, week 26 |
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| Secondary | Absolute Change in Potassium | 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. | Posted | Mean | Standard Deviation | mmol/L | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | kg | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | cm | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | cm | Week 0, week 26 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mg/L | Week 0, week 26 |
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| Secondary | Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) | 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. | Posted | Least Squares Mean | Standard Error | ng/L | Week 0, week 26 |
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| Secondary | Number of Hypoglycaemic Episodes | Number of episodes reported during the trial. | Full analysis set is all randomised subjects who were exposed at least one dose of the trial product. | Posted | Number | episodes | Weeks 0-26 |
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| Secondary | Number of Non-serious Adverse Events | Number of episodes reported during the trial. | Full analysis set is all randomised subjects who were exposed at least one dose of the trial product. | Posted | Number | events | Weeks 0-26 |
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| 3 |
| 24 |
| 18 |
| 24 |
| EG001 | 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 | 3 | 35 | 29 | 35 |
| Insulin aspart overdose | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
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| Crushed vertebra D-12 | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
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| White carotid ictus | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
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| Ischaemic cardiopathy | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
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| Vascular ulcer worsening | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
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| Abdominal pain, upper | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
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| Pain | General disorders | MedDRA (unspecified) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
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Not provided
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |