CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
Semaglutide (administered by DV3396 pen) +1 moredrug
Likely dose
Semaglutide (administered by DV3396 pen) 0.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04007107
NCT04007107Phase 2Completed
CompareCT.gov

A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide sc Administered by 2 Different Products

Novo Nordisk A/S·interventional·Posted Jul 5, 2019·Updated Aug 4, 2020

In Brief

A Phase 2 clinical trial evaluating Semaglutide (administered by DV3396 pen) and Semaglutide (administered by PDS290 pen) for Healthy Volunteers Diabetes Mellitus, Type 2 and 2 related conditions. Completed, enrolled 103 participants across 1 site.

Detailed Summary

This study in healthy men and women compares 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 (sc, 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers Diabetes Mellitus, Type 2, Healthy Volunteers Overweight, Healthy Volunteers Obesity
CountriesNetherlands
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartJun 27, 2019
Primary CompletionJul 28, 2019
Study CompletionSep 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.0 years ago

Interventions

Semaglutide (administered by DV3396 pen)drug

Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day

Semaglutide (administered by PDS290 pen)drug

Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day