Trial Outcomes & Findings for Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes (NCT NCT00509925)
NCT ID: NCT00509925
Last Updated: 2017-03-10
Results Overview
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.
TERMINATED
PHASE4
23 participants
Weeks 14-16, weeks 30-32
2017-03-10
Participant Flow
One single site in United Kingdom.
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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Personal reasons
|
0
|
1
|
Baseline Characteristics
Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Entire Trial Population
n=23 Participants
The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=5 Participants
|
|
BMI
|
28.0 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Body composition: Fat Mass
|
21.3 kg
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Body composition: Lean Body Mass
|
60.6 kg
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
FPG
|
10.4 mmol/L
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
HbA1c
|
8.2 percentage of total haemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Height
|
1.7 meters
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Waist:hip ratio
|
93.5 percentage of hip circumference
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Weight
|
81.9 kg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 14-16, weeks 30-32Population: 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.
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.
Outcome measures
| Measure |
Insulin Detemir
n=13 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=13 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Total Energy Expenditure, Double-labelled Water Method
|
2942.2 kcal/day
Standard Deviation 683.9
|
3007.2 kcal/day
Standard Deviation 649.9
|
PRIMARY outcome
Timeframe: Weeks 14-16, weeks 30-32Population: 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.
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.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Total Energy Expenditure, Dietary Record Method
|
2017.9 kcal/day
Standard Deviation 501.4
|
2181.0 kcal/day
Standard Deviation 559.8
|
SECONDARY outcome
Timeframe: Week 14, week 30Population: 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.
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.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=22 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Component of Total Energy Expenditure: Resting Energy Expenditure (REE)
|
1932.5 kcal/day
Standard Deviation 443.5
|
2034.5 kcal/day
Standard Deviation 368.7
|
SECONDARY outcome
Timeframe: Week 14, week 30Population: 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.
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.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)
|
73.0 kcal/day
Standard Deviation 33.9
|
74.3 kcal/day
Standard Deviation 33.2
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
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).
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Component of Total Energy Expenditure: Physical Activity Thermogenesis
|
588.5 kcal/day
Standard Deviation 358.4
|
542.7 kcal/day
Standard Deviation 281.6
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
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.
Outcome measures
| Measure |
Insulin Detemir
n=17 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=17 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)
|
1163.7 kcal/day
Standard Deviation 1138.7
|
1170.0 kcal/day
Standard Deviation 1084.6
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
Body weight after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=22 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Body Weight
Treatment period 1, N= 12, 10
|
80.6 kg
Standard Deviation 9.8
|
86.0 kg
Standard Deviation 11.7
|
|
Body Weight
Treatment period 2, N= 10, 12
|
82.9 kg
Standard Deviation 10.7
|
84.8 kg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=22 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Lean Body Mass
Treatment period 1, N=12, 10
|
58.9 kg
Standard Deviation 9.9
|
63.7 kg
Standard Deviation 12.3
|
|
Lean Body Mass
Treatment period 2, N=9, 12
|
59.9 kg
Standard Deviation 11.2
|
64.3 kg
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=22 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Fat Mass
Treatment period 1, N=12, 10
|
21.7 kg
Standard Deviation 9.2
|
22.3 kg
Standard Deviation 10.8
|
|
Fat Mass
Treatment period 2, N=9, 12
|
23.0 kg
Standard Deviation 8.5
|
19.2 kg
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
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.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=22 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Waist:Hip Ratio
Treatment period 1, N= 12, 10
|
92.4 percentage of hip circumference
Standard Deviation 9.3
|
94.4 percentage of hip circumference
Standard Deviation 5.9
|
|
Waist:Hip Ratio
Treatment period 2, N= 10, 12
|
92.4 percentage of hip circumference
Standard Deviation 9.4
|
94.8 percentage of hip circumference
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Week 14, week 30Population: 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.
Adiponectin levels after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Hormonal Assessment: Adiponectin
Treatment period 1, N=12, 10
|
15978.3 ng/ml
Standard Deviation 9108.9
|
11361.0 ng/ml
Standard Deviation 3540.7
|
|
Hormonal Assessment: Adiponectin
Treatment period 2, N=9, 11
|
15189.5 ng/ml
Standard Deviation 10470.8
|
11053.3 ng/ml
Standard Deviation 2956.1
|
SECONDARY outcome
Timeframe: Week 14, week 30Population: 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.
Insulin-like growth factor-1 (IGF-1) levels after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=19 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Hormonal Assessment: Insulin-like Growth Factor-1
Treatment period 1, N=12, 9
|
212.3 ng/ml
Standard Deviation 114.5
|
206.8 ng/ml
Standard Deviation 112.2
|
|
Hormonal Assessment: Insulin-like Growth Factor-1
Treatment period 2, N=9, 10
|
179.8 ng/ml
Standard Deviation 76.4
|
168.4 ng/ml
Standard Deviation 60.2
|
SECONDARY outcome
Timeframe: Week 14, week 30Population: 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.
Resistin levels after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Hormonal Assessment: Resistin
Treatment period 1, N=12, 10
|
8.2 ng/ml
Standard Deviation 2.4
|
10.2 ng/ml
Standard Deviation 5.4
|
|
Hormonal Assessment: Resistin
Treatment period 2, N=9, 11
|
8.4 ng/ml
Standard Deviation 2.5
|
16.2 ng/ml
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Week 14, week 30Population: 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.
Leptin levels after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Hormonal Assessment: Leptin
Treatment period 1, N=12, 10
|
9.4 ng/ml
Standard Deviation 7.0
|
10.5 ng/ml
Standard Deviation 12.1
|
|
Hormonal Assessment: Leptin
Treatment period 2, N=9, 11
|
9.9 ng/ml
Standard Deviation 5.9
|
6.6 ng/ml
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
Glycosylated haemoglobin A1c (HbA1c) after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=21 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=22 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Glycosylated Haemoglobin A1c (HbA1c)
Treatment period 1, N=11, 10
|
7.8 percentage of total haemoglobin
Standard Deviation 1.3
|
7.4 percentage of total haemoglobin
Standard Deviation 1.2
|
|
Glycosylated Haemoglobin A1c (HbA1c)
Treatment period 2, N=10, 12
|
7.6 percentage of total haemoglobin
Standard Deviation 1.4
|
8.0 percentage of total haemoglobin
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 16, week 32Population: 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.
Fasting plasma glucose (FPG) after each treatment period.
Outcome measures
| Measure |
Insulin Detemir
n=22 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=21 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Fasting Plasma Glucose
Treatment period 1, N=12, 9
|
13.3 mmol/L
Standard Deviation 5.8
|
10.5 mmol/L
Standard Deviation 5.8
|
|
Fasting Plasma Glucose
Treatment period 2, N=10, 12
|
9.1 mmol/L
Standard Deviation 7.5
|
13.3 mmol/L
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Weeks 0-32Population: The safety analysis set included all randomised and exposed subjects.
Total number of hypoglycaemic episodes experienced in the study.
Outcome measures
| Measure |
Insulin Detemir
n=23 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=23 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Hypoglycaemic Episodes
|
90 episodes
|
109 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-32Population: The safety analysis set included all randomised and exposed subjects.
Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.
Outcome measures
| Measure |
Insulin Detemir
n=23 Participants
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=23 Participants
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Hypoglycaemic Episodes, Diurnal/Nocturnal
Diurnal
|
62 episodes
|
60 episodes
|
|
Hypoglycaemic Episodes, Diurnal/Nocturnal
Nocturnal
|
26 episodes
|
15 episodes
|
|
Hypoglycaemic Episodes, Diurnal/Nocturnal
Time of event not recorded
|
2 episodes
|
34 episodes
|
Adverse Events
Insulin Detemir
Insulin NPH
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Detemir
n=23 participants at risk
Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
Insulin NPH
n=23 participants at risk
Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
|
|---|---|---|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Injury, poisoning and procedural complications
Scratched eye
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
General disorders
Flu-like symptoms
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
General disorders
Injection site induration
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Infections and infestations
Common cold
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Infections and infestations
Bronchitis
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Infections and infestations
Viral gastroenteritis
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Infections and infestations
Viral illness
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Musculoskeletal and connective tissue disorders
Slipped disc
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Psychiatric disorders
Panic attacks
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
0.00%
0/23 • Adverse events were collected from July 2007 to July 2008.
The safety analysis set included all randomised and exposed subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER