NCT04143945

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

Completed Phase 2 Results posted Last updated 20 January 2021

What this trial tests

Phase 2 trial testing Semaglutide (administered by DV3396 pen) in Healthy Volunteers Diabetes Mellitus, Type 2 in 104 participants. Completed in 4 January 2020.

Timeline

28 October 2019

Primary endpoint
4 January 2020

4 January 2020

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	104
Start date	28 October 2019
Primary completion	4 January 2020
Estimated completion	4 January 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Semaglutide (administered by DV3396 pen) — full drug profile →
• Semaglutide (administered by PDS290 pen) — full drug profile →

Conditions studied

• Healthy Volunteers Diabetes Mellitus, Type 2 — all drugs for Healthy Volunteers Diabetes Mellitus, Type 2 →
• Healthy Volunteers Overweight — all drugs for Healthy Volunteers Overweight →
• Healthy Volunteers Obesity — all drugs for Healthy Volunteers Obesity →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy Volunteers Diabetes Mellitus, Type 2 or Healthy Volunteers Overweight. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intensity of Injection Site Pain Primary · 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.

Group	Value	95% CI
DV3396	8.3	± 12.9
PDS290	5.7	± 9.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 28. Results are based on the safety analysis set which included all participants who had received at least 1 injection of semaglutide (included any skin contact with trial product whether the injection was completed or not).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overall Study

Serious: 0/104 (0%)

Deaths: 0/104

Other adverse events (2 terms — click to expand)

Reaction	System	Overall Study
Nausea	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04143945 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector.
   Snitker S, Andersen A, Lindskov PS, van Marle S, et al · · 2022 · cited 4× · PMID 35434913 · DOI 10.1111/dom.14718