NCT04189848

Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

Completed Phase 4 Results posted Last updated 7 November 2022

What this trial tests

Phase 4 trial testing Semaglutide in Healthy Volunteers in 104 participants. Completed in 27 February 2020.

Timeline

3 December 2019

Primary endpoint
29 January 2020

27 February 2020

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	104
Start date	3 December 2019
Primary completion	29 January 2020
Estimated completion	27 February 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Semaglutide (semaglutide) — full drug profile →
• Dulaglutide (DULAGLUTIDE) — full drug profile →

Conditions studied

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

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy Volunteers or Diabetes Mellitus, Type 2. 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 · 1 minute after 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 millimeters (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 horizontal line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.

Group	Value	95% CI
Semaglutide	5.6	± 10.1
Dulaglutide	11.5	± 12.8

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 or dulaglutide (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	—
Decreased Appetite	Metabolism and nutrition disorders	—

Data from ClinicalTrials.gov NCT04189848 adverse events section.

Sponsor's own description

This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same 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 the starting doses with semaglutide and dulaglutide: A randomized, double-blind trial in healthy subjects.
   Snitker S, Andersen A, Berg B, van Marle S, et al · · 2021 · cited 4× · PMID 33591618 · DOI 10.1111/dom.14349