Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003060-59 | EudraCT Number |
Not provided
Not provided
Not provided
See detailed description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.
The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental | Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart |
|
| Treatment period 2 | Experimental | Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Energy Expenditure, Double-labelled Water Method | Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure. | Weeks 14-16, weeks 30-32 |
| Total Energy Expenditure, Dietary Record Method | The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE. | Weeks 14-16, weeks 30-32 |
| Measure | Description | Time Frame |
|---|---|---|
| Component of Total Energy Expenditure: Resting Energy Expenditure (REE) | Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Guildford | GU2 7XX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21593292 | Result | Zachariah S, Sheldon B, Shojaee-Moradie F, Jackson NC, Backhouse K, Johnsen S, Jones RH, Umpleby AM, Russell-Jones DL. Insulin detemir reduces weight gain as a result of reduced food intake in patients with type 1 diabetes. Diabetes Care. 2011 Jul;34(7):1487-91. doi: 10.2337/dc11-0098. Epub 2011 May 18. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Eligible subjects were those with type 1 diabetes treated with insulin for at least 3 months having a body mass index (BMI) of 40.0 kg/m2 at most and a glycosylated haemoglobin A1c (HbA1c) between 7-11% qualifying for an intensified insulin treatment based on the treat-to-target concept. The randomisation target for this study was 30 subjects.
One single site in United Kingdom.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Detemir First, Then Insulin NPH | Insulin detemir + insulin aspart once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2) |
| FG001 | Insulin NPH First, Then Insulin Detemir | Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Trial Population | The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment. |
| 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 | Total Energy Expenditure, Double-labelled Water Method | Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kcal/day | Weeks 14-16, weeks 30-32 |
|
Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
Not provided
| 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 + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
This open-label study was terminated prematurely due to 2 unplanned interim analyses having been performed. At this point, only 23 out of the planned 30 patients had been randomised into the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D007336 | Insulin, Isophane |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| insulin NPH | Drug | Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection |
|
| insulin aspart | Drug | Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection |
|
| Week 14, week 30 |
| Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) | Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake. | Week 14, week 30 |
| Component of Total Energy Expenditure: Physical Activity Thermogenesis | Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32). | Week 16, week 32 |
| Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) | Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT. | Week 16, week 32 |
| Body Weight | Body weight after each treatment period. | Week 16, week 32 |
| Lean Body Mass | Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. | Week 16, week 32 |
| Fat Mass | Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. | Week 16, week 32 |
| Waist:Hip Ratio | At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100. | Week 16, week 32 |
| Hormonal Assessment: Adiponectin | Adiponectin levels after each treatment period. | Week 14, week 30 |
| Hormonal Assessment: Insulin-like Growth Factor-1 | Insulin-like growth factor-1 (IGF-1) levels after each treatment period. | Week 14, week 30 |
| Hormonal Assessment: Resistin | Resistin levels after each treatment period. | Week 14, week 30 |
| Hormonal Assessment: Leptin | Leptin levels after each treatment period. | Week 14, week 30 |
| Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated haemoglobin A1c (HbA1c) after each treatment period. | Week 16, week 32 |
| Fasting Plasma Glucose | Fasting plasma glucose (FPG) after each treatment period. | Week 16, week 32 |
| Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in the study. | Weeks 0-32 |
| Hypoglycaemic Episodes, Diurnal/Nocturnal | Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study. | Weeks 0-32 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Body composition: Fat Mass | Mean | Standard Deviation | kg |
|
| Body composition: Lean Body Mass | Mean | Standard Deviation | kg |
|
| FPG | Fasting plasma glucose | Mean | Standard Deviation | mmol/L |
|
| HbA1c | Glycosylated haemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of total haemoglobin |
|
| Height | Mean | Standard Deviation | meters |
|
| Waist:hip ratio | Waist:hip ratio was calculated as waist average in cm divided by hip average in cm, and multiplied by 100. | Mean | Standard Deviation | percentage of hip circumference |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | Insulin NPH | Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period |
|
|
| Secondary | Component of Total Energy Expenditure: Resting Energy Expenditure (REE) | Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kcal/day | Week 14, week 30 |
|
|
|
| Secondary | Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) | Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kcal/day | Week 14, week 30 |
|
|
|
| Primary | Total Energy Expenditure, Dietary Record Method | The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kcal/day | Weeks 14-16, weeks 30-32 |
|
|
|
| Secondary | Component of Total Energy Expenditure: Physical Activity Thermogenesis | Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32). | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kcal/day | Week 16, week 32 |
|
|
|
| Secondary | Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) | Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kcal/day | Week 16, week 32 |
|
|
|
| Secondary | Body Weight | Body weight after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kg | Week 16, week 32 |
|
|
|
| Secondary | Lean Body Mass | Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kg | Week 16, week 32 |
|
|
|
| Secondary | Fat Mass | Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | kg | Week 16, week 32 |
|
|
|
| Secondary | Waist:Hip Ratio | At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | percentage of hip circumference | Week 16, week 32 |
|
|
|
| Secondary | Hormonal Assessment: Adiponectin | Adiponectin levels after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | ng/ml | Week 14, week 30 |
|
|
|
| Secondary | Hormonal Assessment: Insulin-like Growth Factor-1 | Insulin-like growth factor-1 (IGF-1) levels after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | ng/ml | Week 14, week 30 |
|
|
|
| Secondary | Hormonal Assessment: Resistin | Resistin levels after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | ng/ml | Week 14, week 30 |
|
|
|
| Secondary | Hormonal Assessment: Leptin | Leptin levels after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | ng/ml | Week 14, week 30 |
|
|
|
| Secondary | Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated haemoglobin A1c (HbA1c) after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | percentage of total haemoglobin | Week 16, week 32 |
|
|
|
| Secondary | Fasting Plasma Glucose | Fasting plasma glucose (FPG) after each treatment period. | The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint. | Posted | Mean | Standard Deviation | mmol/L | Week 16, week 32 |
|
|
|
| Secondary | Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in the study. | The safety analysis set included all randomised and exposed subjects. | Posted | Number | episodes | Weeks 0-32 |
|
|
|
| Secondary | Hypoglycaemic Episodes, Diurnal/Nocturnal | Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study. | The safety analysis set included all randomised and exposed subjects. | Posted | Number | episodes | Weeks 0-32 |
|
|
|
| 0 |
| 23 |
| 7 |
| 23 |
| EG001 | Insulin NPH | Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period | 0 | 23 | 4 | 23 |
| Scratched eye | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Flu-like symptoms | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Common cold | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Viral gastroenteritis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Viral illness | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Slipped disc | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Panic attacks | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Allergic reaction | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| Time of event not recorded |
|