Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGinsulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
DRUGinsulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
DRUGinsulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for more than 12 months * Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal) * HbA1c (glycosylated haemoglobin A1c) between 7.0 and 11.0% * Able and willing to maintain consistent physical activity level throughout the entire study period * Able and willing to maintain consistent eating habits throughout the entire study period
Exclusion criteria
* Proliferative retinopathy that has required acute treatment within the last six months * Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator * Liver, kidney or heart problems as judged by the Investigator * Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures * Known or suspected allergy to trial products or related products * Receipt of any investigational drug within one month prior to this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Energy Expenditure, Double-labelled Water Method | Weeks 14-16, weeks 30-32 | 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. |
| Total Energy Expenditure, Dietary Record Method | Weeks 14-16, weeks 30-32 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Component of Total Energy Expenditure: Physical Activity Thermogenesis | Week 16, week 32 | 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). |
| Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) | Week 16, week 32 | 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. |
| Body Weight | Week 16, week 32 | Body weight after each treatment period. |
| Lean Body Mass | Week 16, week 32 | Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. |
| Fat Mass | Week 16, week 32 | Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition. |
| Waist:Hip Ratio | Week 16, week 32 | 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. |
| Hormonal Assessment: Adiponectin | Week 14, week 30 | Adiponectin levels after each treatment period. |
| Component of Total Energy Expenditure: Resting Energy Expenditure (REE) | Week 14, week 30 | 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. |
| Hormonal Assessment: Resistin | Week 14, week 30 | Resistin levels after each treatment period. |
| Hormonal Assessment: Leptin | Week 14, week 30 | Leptin levels after each treatment period. |
| Glycosylated Haemoglobin A1c (HbA1c) | Week 16, week 32 | Glycosylated haemoglobin A1c (HbA1c) after each treatment period. |
| Fasting Plasma Glucose | Week 16, week 32 | Fasting plasma glucose (FPG) after each treatment period. |
| Hypoglycaemic Episodes | Weeks 0-32 | Total number of hypoglycaemic episodes experienced in the study. |
| Hypoglycaemic Episodes, Diurnal/Nocturnal | Weeks 0-32 | Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study. |
| Hormonal Assessment: Insulin-like Growth Factor-1 | Week 14, week 30 | Insulin-like growth factor-1 (IGF-1) levels after each treatment period. |
| Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) | Week 14, week 30 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
One single site in United Kingdom.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Trial Population The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Personal reasons | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Trial Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 38.8 years STANDARD_DEVIATION 10.6 |
| BMI | 28.0 kg/m^2 STANDARD_DEVIATION 3.6 |
| Body composition: Fat Mass | 21.3 kg STANDARD_DEVIATION 9.3 |
| Body composition: Lean Body Mass | 60.6 kg STANDARD_DEVIATION 10.8 |
| FPG | 10.4 mmol/L STANDARD_DEVIATION 3.6 |
| HbA1c | 8.2 percentage of total haemoglobin STANDARD_DEVIATION 1 |
| Height | 1.7 meters STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United Kingdom | 23 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 14 Participants |
| Waist:hip ratio | 93.5 percentage of hip circumference STANDARD_DEVIATION 7.5 |
| Weight | 81.9 kg STANDARD_DEVIATION 10.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 23 | 4 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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.
Time frame: Weeks 14-16, weeks 30-32
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Total Energy Expenditure, Dietary Record Method | 2017.9 kcal/day | Standard Deviation 501.4 |
| Insulin NPH | Total Energy Expenditure, Dietary Record Method | 2181.0 kcal/day | Standard Deviation 559.8 |
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.
Time frame: Weeks 14-16, weeks 30-32
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Total Energy Expenditure, Double-labelled Water Method | 2942.2 kcal/day | Standard Deviation 683.9 |
| Insulin NPH | Total Energy Expenditure, Double-labelled Water Method | 3007.2 kcal/day | Standard Deviation 649.9 |
Secondary
Body Weight
Body weight after each treatment period.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Body Weight | Treatment period 1, N= 12, 10 | 80.6 kg | Standard Deviation 9.8 |
| Insulin Detemir | Body Weight | Treatment period 2, N= 10, 12 | 82.9 kg | Standard Deviation 10.7 |
| Insulin NPH | Body Weight | Treatment period 1, N= 12, 10 | 86.0 kg | Standard Deviation 11.7 |
| Insulin NPH | Body Weight | Treatment period 2, N= 10, 12 | 84.8 kg | Standard Deviation 11.6 |
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.
Time frame: Week 14, week 30
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) | 73.0 kcal/day | Standard Deviation 33.9 |
| Insulin NPH | Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) | 74.3 kcal/day | Standard Deviation 33.2 |
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.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) | 1163.7 kcal/day | Standard Deviation 1138.7 |
| Insulin NPH | Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) | 1170.0 kcal/day | Standard Deviation 1084.6 |
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).
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Component of Total Energy Expenditure: Physical Activity Thermogenesis | 588.5 kcal/day | Standard Deviation 358.4 |
| Insulin NPH | Component of Total Energy Expenditure: Physical Activity Thermogenesis | 542.7 kcal/day | Standard Deviation 281.6 |
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.
Time frame: Week 14, week 30
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir | Component of Total Energy Expenditure: Resting Energy Expenditure (REE) | 1932.5 kcal/day | Standard Deviation 443.5 |
| Insulin NPH | Component of Total Energy Expenditure: Resting Energy Expenditure (REE) | 2034.5 kcal/day | Standard Deviation 368.7 |
Secondary
Fasting Plasma Glucose
Fasting plasma glucose (FPG) after each treatment period.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Fasting Plasma Glucose | Treatment period 1, N=12, 9 | 13.3 mmol/L | Standard Deviation 5.8 |
| Insulin Detemir | Fasting Plasma Glucose | Treatment period 2, N=10, 12 | 9.1 mmol/L | Standard Deviation 7.5 |
| Insulin NPH | Fasting Plasma Glucose | Treatment period 1, N=12, 9 | 10.5 mmol/L | Standard Deviation 5.8 |
| Insulin NPH | Fasting Plasma Glucose | Treatment period 2, N=10, 12 | 13.3 mmol/L | Standard Deviation 5.2 |
Secondary
Fat Mass
Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Fat Mass | Treatment period 1, N=12, 10 | 21.7 kg | Standard Deviation 9.2 |
| Insulin Detemir | Fat Mass | Treatment period 2, N=9, 12 | 23.0 kg | Standard Deviation 8.5 |
| Insulin NPH | Fat Mass | Treatment period 1, N=12, 10 | 22.3 kg | Standard Deviation 10.8 |
| Insulin NPH | Fat Mass | Treatment period 2, N=9, 12 | 19.2 kg | Standard Deviation 8.5 |
Secondary
Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated haemoglobin A1c (HbA1c) after each treatment period.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Glycosylated Haemoglobin A1c (HbA1c) | Treatment period 1, N=11, 10 | 7.8 percentage of total haemoglobin | Standard Deviation 1.3 |
| Insulin Detemir | Glycosylated Haemoglobin A1c (HbA1c) | Treatment period 2, N=10, 12 | 7.6 percentage of total haemoglobin | Standard Deviation 1.4 |
| Insulin NPH | Glycosylated Haemoglobin A1c (HbA1c) | Treatment period 1, N=11, 10 | 7.4 percentage of total haemoglobin | Standard Deviation 1.2 |
| Insulin NPH | Glycosylated Haemoglobin A1c (HbA1c) | Treatment period 2, N=10, 12 | 8.0 percentage of total haemoglobin | Standard Deviation 1 |
Secondary
Hormonal Assessment: Adiponectin
Adiponectin levels after each treatment period.
Time frame: Week 14, week 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Hormonal Assessment: Adiponectin | Treatment period 1, N=12, 10 | 15978.3 ng/ml | Standard Deviation 9108.9 |
| Insulin Detemir | Hormonal Assessment: Adiponectin | Treatment period 2, N=9, 11 | 15189.5 ng/ml | Standard Deviation 10470.8 |
| Insulin NPH | Hormonal Assessment: Adiponectin | Treatment period 1, N=12, 10 | 11361.0 ng/ml | Standard Deviation 3540.7 |
| Insulin NPH | Hormonal Assessment: Adiponectin | Treatment period 2, N=9, 11 | 11053.3 ng/ml | Standard Deviation 2956.1 |
Secondary
Hormonal Assessment: Insulin-like Growth Factor-1
Insulin-like growth factor-1 (IGF-1) levels after each treatment period.
Time frame: Week 14, week 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Hormonal Assessment: Insulin-like Growth Factor-1 | Treatment period 1, N=12, 9 | 212.3 ng/ml | Standard Deviation 114.5 |
| Insulin Detemir | Hormonal Assessment: Insulin-like Growth Factor-1 | Treatment period 2, N=9, 10 | 179.8 ng/ml | Standard Deviation 76.4 |
| Insulin NPH | Hormonal Assessment: Insulin-like Growth Factor-1 | Treatment period 1, N=12, 9 | 206.8 ng/ml | Standard Deviation 112.2 |
| Insulin NPH | Hormonal Assessment: Insulin-like Growth Factor-1 | Treatment period 2, N=9, 10 | 168.4 ng/ml | Standard Deviation 60.2 |
Secondary
Hormonal Assessment: Leptin
Leptin levels after each treatment period.
Time frame: Week 14, week 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Hormonal Assessment: Leptin | Treatment period 1, N=12, 10 | 9.4 ng/ml | Standard Deviation 7 |
| Insulin Detemir | Hormonal Assessment: Leptin | Treatment period 2, N=9, 11 | 9.9 ng/ml | Standard Deviation 5.9 |
| Insulin NPH | Hormonal Assessment: Leptin | Treatment period 1, N=12, 10 | 10.5 ng/ml | Standard Deviation 12.1 |
| Insulin NPH | Hormonal Assessment: Leptin | Treatment period 2, N=9, 11 | 6.6 ng/ml | Standard Deviation 7.7 |
Secondary
Hormonal Assessment: Resistin
Resistin levels after each treatment period.
Time frame: Week 14, week 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Hormonal Assessment: Resistin | Treatment period 1, N=12, 10 | 8.2 ng/ml | Standard Deviation 2.4 |
| Insulin Detemir | Hormonal Assessment: Resistin | Treatment period 2, N=9, 11 | 8.4 ng/ml | Standard Deviation 2.5 |
| Insulin NPH | Hormonal Assessment: Resistin | Treatment period 1, N=12, 10 | 10.2 ng/ml | Standard Deviation 5.4 |
| Insulin NPH | Hormonal Assessment: Resistin | Treatment period 2, N=9, 11 | 16.2 ng/ml | Standard Deviation 13.2 |
Secondary
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in the study.
Time frame: Weeks 0-32
Population: The safety analysis set included all randomised and exposed subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir | Hypoglycaemic Episodes | 90 episodes |
| Insulin NPH | Hypoglycaemic Episodes | 109 episodes |
Secondary
Hypoglycaemic Episodes, Diurnal/Nocturnal
Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.
Time frame: Weeks 0-32
Population: The safety analysis set included all randomised and exposed subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Detemir | Hypoglycaemic Episodes, Diurnal/Nocturnal | Diurnal | 62 episodes |
| Insulin Detemir | Hypoglycaemic Episodes, Diurnal/Nocturnal | Nocturnal | 26 episodes |
| Insulin Detemir | Hypoglycaemic Episodes, Diurnal/Nocturnal | Time of event not recorded | 2 episodes |
| Insulin NPH | Hypoglycaemic Episodes, Diurnal/Nocturnal | Diurnal | 60 episodes |
| Insulin NPH | Hypoglycaemic Episodes, Diurnal/Nocturnal | Nocturnal | 15 episodes |
| Insulin NPH | Hypoglycaemic Episodes, Diurnal/Nocturnal | Time of event not recorded | 34 episodes |
Secondary
Lean Body Mass
Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Lean Body Mass | Treatment period 2, N=9, 12 | 59.9 kg | Standard Deviation 11.2 |
| Insulin Detemir | Lean Body Mass | Treatment period 1, N=12, 10 | 58.9 kg | Standard Deviation 9.9 |
| Insulin NPH | Lean Body Mass | Treatment period 1, N=12, 10 | 63.7 kg | Standard Deviation 12.3 |
| Insulin NPH | Lean Body Mass | Treatment period 2, N=9, 12 | 64.3 kg | Standard Deviation 12 |
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.
Time frame: Week 16, week 32
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir | Waist:Hip Ratio | Treatment period 1, N= 12, 10 | 92.4 percentage of hip circumference | Standard Deviation 9.3 |
| Insulin Detemir | Waist:Hip Ratio | Treatment period 2, N= 10, 12 | 92.4 percentage of hip circumference | Standard Deviation 9.4 |
| Insulin NPH | Waist:Hip Ratio | Treatment period 1, N= 12, 10 | 94.4 percentage of hip circumference | Standard Deviation 5.9 |
| Insulin NPH | Waist:Hip Ratio | Treatment period 2, N= 10, 12 | 94.8 percentage of hip circumference | Standard Deviation 5.6 |