Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01680328
Collaborator
(none)
82
1
1
2
40.9
Study Details
Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
82 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Study Start Date
:
Aug 1, 2012
Actual Primary Completion Date
:
Oct 1, 2012
Actual Study Completion Date
:
Oct 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Different injection speed and volume combinations The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods. The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject. A subject not completing all treatments will be replaced by another subject using the same treatment arm. |
Other: 19 injections
Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).
Drug: sodium chloride 0.9% solution
Solution for injection.
|
Outcome Measures
Primary Outcome Measures
- Injection Pain (VAS mm) [1 minute (±30 sec) after each injection]
Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).
Secondary Outcome Measures
- Acceptance of Injection Pain After Injection of Different Volumes. [1 minute (±30 seconds) after each injection]
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
- Acceptance of Injection Pain After Injection at Different Speeds. [1 minute (±30 sec) after each injection]
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
- Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. [1 minute (±30 seconds) after each injection]
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
- Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion [2 minutes (±30sec) after each injection]
Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
- Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion [2 minutes (±30sec) after each injection]
Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Informed consent obtained before any trial-related activities.
-
Type 1 or type 2 diabetes
-
Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months
-
Body mass index (BMI) between 18.5 and 30.0 kg/m^2 (both included)
-
Caucasians
Exclusion Criteria:
-
Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
-
Previous participation in this trial. Participation is defined as: screened
-
Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
-
Injection of more than 40 units of insulin per injection
-
Continuous Subcutaneous Insulin Infusion use within the last 6 months
-
Continuous Glucose Monitoring use within the last 6 months
-
Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
-
Known active or in-active skin disease in the injection area or that may affect pain perception
-
Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01680328
Other Study ID Numbers:
- INS-4011
- U1111-1129-4191
First Posted:
Sep 7, 2012
Last Update Posted:
Mar 3, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The trial was conducted at a single site in Germany at a single visit. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected. |
| Period Title: Overall Study | |
| STARTED | 82 |
| Subjects Missing Injections | 2 |
| COMPLETED | 80 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected. |
| Overall Participants | 82 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.3
(11.9)
|
| Gender (Count of Participants) | |
| Female |
32
39%
|
| Male |
50
61%
|
Outcome Measures
| Title | Injection Pain (VAS mm) |
|---|---|
| Description | Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line). |
| Time Frame | 1 minute (±30 sec) after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2). |
| Arm/Group Title | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion | Injection Volume 1600 μL | Injection Volume 1200 μL | Injection Volume 800 μL | Injection Volume 400 μL | Injection Speed at 450 μL/s | Injection Speed at 300 μL/s | Injection Speed at 150 μL/s |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs. | Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen. | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). |
| Measure Participants | 82 | 82 | 82 | 82 | 82 | 82 | 82 | 82 | 82 |
| Needle insertion |
20.0
(24.2)
|
12.8
(16.3)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 150 μL/s; Abdomen |
NA
(NA)
|
NA
(NA)
|
20.9
(24.4)
|
15.7
(20.2)
|
11.6
(15.7)
|
14.5
(17.3)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 300 μL/s; Abdomen |
NA
(NA)
|
NA
(NA)
|
17.2
(22.5)
|
20.1
(25.3)
|
13.7
(17.1)
|
14.8
(18.1)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 450 μL/s; Abdomen |
NA
(NA)
|
NA
(NA)
|
21.1
(24.8)
|
14.9
(16.9)
|
14.8
(18.9)
|
12.4
(15.5)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection volume of 400 μL; Thighs |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
20.9
(24.8)
|
NA
(NA)
|
22.9
(25.9)
|
| Injection volume of 800 μL; Thighs |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
23.2
(24.5)
|
NA
(NA)
|
| Injection volume of 1600 μL; Thighs |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
31.1
(28.5)
|
NA
(NA)
|
31.5
(28.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 800 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | -0.1 | |
| Confidence Interval |
() 95% -2.9 to 2.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 3.5 | |
| Confidence Interval |
() 95% 0.4 to 6.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 7.2 | |
| Confidence Interval |
() 95% 4.6 to 9.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Volume 800 μL |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 3.6 | |
| Confidence Interval |
() 95% 0.4 to 6.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Volume 800 μL |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 7.2 | |
| Confidence Interval |
() 95% 4.4 to 10.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Volume 1200 μL |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 3.7 | |
| Confidence Interval |
() 95% 0.6 to 6.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Injection Speed at 300 μL/s, Injection Speed at 150 μL/s |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 0.4 | |
| Confidence Interval |
() 95% -2.1 to 2.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Injection Speed at 450 μL/s, Injection Speed at 150 μL/s |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | -0.4 | |
| Confidence Interval |
() 95% -2.7 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion, Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion |
|---|---|---|
| Comments | Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | 9.0 | |
| Confidence Interval |
() 95% 6.7 to 11.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Acceptance of Injection Pain After Injection of Different Volumes. |
|---|---|
| Description | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. |
| Time Frame | 1 minute (±30 seconds) after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. |
| Arm/Group Title | Injection Volume of 1600 μL | Injection Volume of 1200 μL | Injection Volume of 800 μL | Injection Volume of 400 μL |
|---|---|---|---|---|
| Arm/Group Description | Acceptance of pain was assessed in each subject for all injections. | Acceptance of pain was assessed in each subject for all injections. | Acceptance of pain was assessed in each subject for all injections. | Acceptance of pain was assessed in each subject for all injections. |
| Measure Participants | 82 | 82 | 82 | 82 |
| Yes |
334
|
218
|
303
|
368
|
| No |
75
|
28
|
25
|
41
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Volume 1200 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.8 | |
| Confidence Interval |
() 95% 0.5 to 1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Volume 1200 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.1 | |
| Confidence Interval |
() 95% 1.2 to 3.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion, Injection Volume 1200 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.1 | |
| Confidence Interval |
() 95% 1.4 to 3.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Volume 1600 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.6 | |
| Confidence Interval |
() 95% 1.4 to 4.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion, Injection Volume 1600 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.6 | |
| Confidence Interval |
() 95% 1.4 to 4.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion, Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.0 | |
| Confidence Interval |
() 95% 0.7 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Acceptance of Injection Pain After Injection at Different Speeds. |
|---|---|
| Description | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. |
| Time Frame | 1 minute (±30 sec) after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. |
| Arm/Group Title | Injection Speed at 450 μL/s | Injection Speed at 300 μL/s | Injection Speed at 150 μL/s |
|---|---|---|---|
| Arm/Group Description | Acceptance of pain was assessed in each subject for all injections. | Acceptance of pain was assessed in each subject for all injections. | Acceptance of pain was assessed in each subject for all injections. |
| Measure Participants | 82 | 82 | 82 |
| Yes |
432
|
365
|
426
|
| No |
59
|
44
|
66
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Volume 1600 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.1 | |
| Confidence Interval |
() 95% 0.7 to 1.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion, Injection Volume 1600 μL |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.9 | |
| Confidence Interval |
() 95% 0.6 to 1.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. |
|---|---|
| Description | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. |
| Time Frame | 1 minute (±30 seconds) after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. |
| Arm/Group Title | Thighs | Abdomen |
|---|---|---|
| Arm/Group Description | Acceptance of pain was assessed in each subject for all injections in the thighs. | Acceptance of pain was assessed in each subject for all injections in the abdomen. |
| Measure Participants | 82 | 82 |
| Yes |
390
|
978
|
| No |
101
|
87
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion, Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion |
|---|---|---|
| Comments | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.7 | |
| Confidence Interval |
() 95% 2.4 to 5.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion |
|---|---|
| Description | Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations. |
| Time Frame | 2 minutes (±30sec) after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection. |
| Arm/Group Title | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion | Injection Volume 1600 μL | Injection Volume 1200 μL | Injection Volume 800 μL | Injection Volume 400 μL | Injection Speed at 450 μL/s | Injection Speed at 300 μL/s | Injection Speed at 150 μL/s |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen. | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). |
| Measure Participants | 82 | 82 | 82 | 82 | 82 | 82 | 82 | 82 |
| Needle insertion |
0.0
(0.1)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 150 μL/s |
NA
(NA)
|
2.3
(5.1)
|
0.9
(1.9)
|
0.5
(1.4)
|
0.6
(1.8)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 300 μL/s |
NA
(NA)
|
1.4
(2.9)
|
0.8
(1.9)
|
0.5
(1.6)
|
0.4
(1.3)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 450 μL/s |
NA
(NA)
|
0.6
(1.1)
|
1.1
(4.6)
|
0.5
(1.3)
|
0.9
(2.7)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 800 μL, Injection Speed at 300 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.6 | |
| Confidence Interval |
() 95% -0.6 to 1.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 800 μL, Injection Speed at 450 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.4 | |
| Confidence Interval |
() 95% -0.8 to 1.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 800 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.9 | |
| Confidence Interval |
() 95% -0.4 to 2.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Speed at 300 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.5 | |
| Confidence Interval |
() 95% -0.8 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Speed at 450 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.5 | |
| Confidence Interval |
() 95% -0.8 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.5 | |
| Confidence Interval |
() 95% -0.7 to 1.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Speed at 300 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.9 | |
| Confidence Interval |
() 95% -0.3 to 2.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Speed at 450 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.8 | |
| Confidence Interval |
() 95% -0.4 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 1.1 | |
| Confidence Interval |
() 95% -0.1 to 2.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Speed at 300 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 2.3 | |
| Confidence Interval |
() 95% 1.0 to 3.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Speed at 450 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 1.4 | |
| Confidence Interval |
() 95% 0.2 to 2.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Volume 400 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.6 | |
| Confidence Interval |
() 95% -0.6 to 1.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion |
|---|---|
| Description | Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations. |
| Time Frame | 2 minutes (±30sec) after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection. |
| Arm/Group Title | Thighs: Injection Region-5 s.c Injections+1 Needle Insertion | Injection Volume 1600 μL | Injection Volume 800 μL | Injection Volume 400 μL | Injection Speed at 450 μL/s | Injection Speed at 300 μL/s | Injection Speed at 150 μL/s |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs. | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). | Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). |
| Measure Participants | 82 | 82 | 82 | 82 | 82 | 82 | 82 |
| Needle insertion |
0.8
(5.6)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 150 μL/s |
NA
(NA)
|
5.6
(8.6)
|
NA
(NA)
|
1.0
(3.1)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 300 μL/s |
NA
(NA)
|
NA
(NA)
|
2.3
(7.9)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Injection speed at 450 μL/s |
NA
(NA)
|
2.5
(4.6)
|
NA
(NA)
|
1.6
(4.9)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Speed at 450 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.3 | |
| Confidence Interval |
() 95% -0.9 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1200 μL, Injection Volume 800 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 0.8 | |
| Confidence Interval |
() 95% -0.4 to 2.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Injection Volume 1600 μL, Injection Volume 400 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 1.6 | |
| Confidence Interval |
() 95% 0.3 to 2.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Speed at 450 μL/s |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 4.9 | |
| Confidence Interval |
() 95% 3.7 to 6.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion, Injection Volume 800 μL |
|---|---|---|
| Comments | Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | 1.7 | |
| Confidence Interval |
() 95% 0.5 to 2.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From Day 0 when receiving 19 injections and up to 48 hours after last injection. | |
|---|---|---|
| Adverse Event Reporting Description | All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the safety analysis set. | |
| Arm/Group Title | All Participants | |
| Arm/Group Description | Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected. | |
All Cause Mortality |
||
| All Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| All Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/82 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/82 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Novo Nordisk reserves the right to defer the release of data until specified milestones are reached, for example when the clinical trial report is available. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
| Name/Title | Public Access to Clinical Trials |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01680328
Other Study ID Numbers:
- INS-4011
- U1111-1129-4191
First Posted:
Sep 7, 2012
Last Update Posted:
Mar 3, 2017
Last Verified:
Jan 1, 2017