Intensity of Injection Site Pain
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| DV3396 | 8.3 | 12.9 |
| PDS290 | 5.7 | 9.3 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataNetherlands
1 trial · 1 completed · 1 with posted results
A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
NCT0414394528 Oct 2019 to 4 Jan 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study in healthy men and women looks at the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (s.c., under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.
Experimental
DV3396 followed by PDS290
The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach
Experimental
PDS290 followed by DV3396
The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach
Outcomes the sponsor listed as primary.
Intensity of Injection Site Pain
Time frame · After 1 minute of each injection (Day 1)
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| DV3396 | 8.3 | 12.9 |
| PDS290 | 5.7 | 9.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Overall StudyParticipants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other. | 0 / 104 | 0 / 104 | 28 / 104 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
PubMed tag: none · 2022
Snitker et al. 2022Diabetes, obesity & metabolismcited by 4
PMID 35434913PMC9545130DOI 10.1111/dom.14718PUB-35434913
Who could join, as posted.
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