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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT04007107 (opens ClinicalTrials.gov in a new tab)Other idINS-4582Other id2019-002284-10Other idU1111-1233-9590Other id2019

Overview

Status
Completed
Phase
Phase 2
Enrollment
103 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Netherlands

Start
27 Jun 2019
Primary completion
28 Jul 2019
Completion
4 Sept 2019
First posted
5 Jul 2019
Last update posted
4 Aug 2020
Conditions
Healthy Volunteers Diabetes Mellitus, Type 2 · Healthy Volunteers Overweight · Healthy Volunteers Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020
  1. Ph 2

    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

    NCT04007107

    27 Jun 2019 to 4 Sept 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Semaglutide (administered by DV3396 pen)Drug
  • Semaglutide (administered by PDS290 pen)Drug

Arms2

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Intensity of Injection Site Pain

    Time frame · After 1 minute of each injection (Day 1)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· After 1 minute of each injection (Day 1)

Intensity of Injection Site Pain

GroupValue (score on a scale)Spread
DV339635.123.1
PDS2904.47.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 1030 / 10315 / 103

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2022

Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector.

Snitker et al. 2022Diabetes, obesity & metabolismcited by 4

PMID 35434913PMC9545130DOI 10.1111/dom.14718PUB-35434913

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing informed consent. * BMI equal to or above 25.0 kg/m\^2 * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the Investigator. Exclusion Criteria: * Known or suspected hypersensitivity to the study product or related products. * Previous participation in this study. Participation is defined as having received investigational product. * Woman who is pregnant or breast-feeding or intends to become pregnant within 4 weeks after administration of the study drug, or is of childbearing potential and not using highly effective contraceptive methods with her fertile male sexual partner * Participation in a drug study within 60 days prior to drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to drug administration in the current study. * Any disorder that in the Investigator's opinion might jeopardize subject's safety, evaluation of results, or compliance with the protocol. * Glycosylated haemoglobin (HbA1c) equal to or above 6.5% at screening. * Supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90 to 160 mmHg for systolic or 45 to 89 mmHg for diastolic. * Supine pulse rate (as part of vital signs) (after resting for at least 5 minutes) outside the range of 40 to 100 beats per minute. * Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives, and occasional use of paracetamol (paracetamol not allowed within 24 hours prior to drug administration), within 14 days prior to drug administration. * Diagnostic test results positive for human immunodeficiency virus (HIV)-1 or HIV-2 infection. * Diagnostic test results positive for hepatitis B or hepatitis C infection. * Mental incapacity, language barriers, or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the Investigator. * Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits. * Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center. * Use of tobacco and nicotine products, defined as any of the below: * Smoking more than 1 cigarette or the equivalent per day on average * Not able or willing to refrain from smoking and the use of nicotine substitute products during the in-house period * Blood donation, plasma donation or blood draw (as declared by the subject or reported in the medical records): * In excess of 400 mL within the past 90 days prior to the day of screening * In excess of 50 mL within the past 30 days prior to the day of screening * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records) * Subjects with a history of malignant neoplasms within the past 5 years prior to screening. * Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records). * Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the study requirements. * Subject depends on the Sponsor, the Investigator, or the study center, or subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study. * Vulnerable subject (eg, person kept in detention) who may have an increased likelihood of being wronged or of incurring additional harm.

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