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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1129-4191 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Different injection speed and volume combinations | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19 injections | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Injection Pain (VAS mm) | 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). | 1 minute (±30 sec) after each injection |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of Injection Pain After Injection of Different Volumes. | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. | 1 minute (±30 seconds) after each injection |
| Acceptance of Injection Pain After Injection at Different Speeds. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24720741 | Result | Heise T, Nosek L, Dellweg S, Zijlstra E, Praestmark KA, Kildegaard J, Nielsen G, Sparre T. Impact of injection speed and volume on perceived pain during subcutaneous injections into the abdomen and thigh: a single-centre, randomized controlled trial. Diabetes Obes Metab. 2014 Oct;16(10):971-6. doi: 10.1111/dom.12304. Epub 2014 May 11. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted at a single site in Germany at a single visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| sodium chloride 0.9% solution | Drug | Solution for injection. |
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Acceptance of pain was rated subjectively as yes or no by the subject after each injection. |
| 1 minute (±30 sec) after each injection |
| Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. | 1 minute (±30 seconds) 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 | 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. | 2 minutes (±30sec) after each injection |
| Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion | 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. | 2 minutes (±30sec) after each injection |
| Subjects Missing Injections |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Injection Pain (VAS mm) | 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). | 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). | Posted | Mean | Standard Deviation | mm | 1 minute (±30 sec) after each injection |
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| Secondary | Acceptance of Injection Pain After Injection of Different Volumes. | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. | All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. | Posted | Number | scores | 1 minute (±30 seconds) after each injection |
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| Secondary | Acceptance of Injection Pain After Injection at Different Speeds. | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. | All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. | Posted | Number | scores | 1 minute (±30 sec) after each injection |
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| Secondary | Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. | Acceptance of pain was rated subjectively as yes or no by the subject after each injection. | All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. | Posted | Number | scores | 1 minute (±30 seconds) after each injection |
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| Secondary | Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion | 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. | 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. | Posted | Mean | Standard Deviation | mcL | 2 minutes (±30sec) after each injection |
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| Secondary | Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion | 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. | 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. | Posted | Mean | Standard Deviation | mcL | 2 minutes (±30sec) after each injection |
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From Day 0 when receiving 19 injections and up to 48 hours after last injection.
All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | 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. | 0 | 82 | 0 | 82 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004364 | Pharmaceutical Preparations |
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| Injection speed at 150 μL/s; Abdomen |
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| Injection speed at 300 μL/s; Abdomen |
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| Injection speed at 450 μL/s; Abdomen |
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| Injection volume of 400 μL; Thighs |
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| Injection volume of 800 μL; Thighs |
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| Injection volume of 1600 μL; Thighs |
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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. |
| Least Squares Mean |
| 3.5 |
| 95 |
| 0.4 |
| 6.6 |
| No |
| Superiority or Other |
| 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. | Least Squares Mean | 7.2 | 95 | 4.6 | 9.7 | No | Superiority or Other |
| 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. | Least Squares Mean | 3.6 | 95 | 0.4 | 6.7 | No | Superiority or Other |
| 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. | Least Squares Mean | 7.2 | 95 | 4.4 | 10.0 | No | Superiority or Other |
| 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. | Least Squares Mean | 3.7 | 95 | 0.6 | 6.7 | No | Superiority or Other |
| 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. | Least Squares Mean | 0.4 | 95 | -2.1 | 2.9 | No | Superiority or Other |
| 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. | Least Squares Mean | -0.4 | 95 | -2.7 | 1.9 | No | Superiority or Other |
| 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. | Least Squares Mean | 9.0 | 95 | 6.7 | 11.3 | No | Superiority or Other |
| Units | Counts |
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| OG002 | Injection Volume 1200 μL | 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). |
| OG003 | Injection Volume 800 μL | 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). |
| OG004 | Injection Volume 400 μL | 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). |
| OG005 | Injection Speed at 450 μL/s | 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). |
| OG006 | Injection Speed at 300 μL/s | 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). |
| OG007 | Injection Speed at 150 μL/s | 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). |
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| OG002 | Injection Volume 800 μL | 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). |
| OG003 | Injection Volume 400 μL | 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). |
| OG004 | Injection Speed at 450 μL/s | 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). |
| OG005 | Injection Speed at 300 μL/s | 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). |
| OG006 | Injection Speed at 150 μL/s | 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). |
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