| Trial ID: | L6203 |
| Source ID: | NCT04007107
|
| Associated Drug: |
Semaglutide (Administered By Dv3396 Pen)
|
| Title: |
A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04007107/results
|
| Conditions: |
Healthy Volunteers Diabetes Mellitus, Type 2|Healthy Volunteers Overweight|Healthy Volunteers Obesity
|
| Interventions: |
DRUG: Semaglutide (administered by DV3396 pen)|DRUG: Semaglutide (administered by PDS290 pen)
|
| Outcome Measures: |
Primary: Intensity of Injection Site Pain, The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimetres (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed., After 1 minute of each injection (Day 1) |
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| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
|
| Enrollment: |
103
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2019-06-27
|
| Completion Date: |
2019-09-04
|
| Results First Posted: |
2020-08-04
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| Last Update Posted: |
2020-08-04
|
| Locations: |
Novo Nordisk Investigational Site, Groningen, 9728 NZ, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT04007107
|
