Healthy Volunteers Diabetes Mellitus, Type 2Phase 2NCT04143945

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

A Phase 2 study testing Semaglutide (administered by DV3396 pen) and Semaglutide (administered by PDS290 pen) in people with Healthy Volunteers Diabetes Mellitus, Type 2 and Healthy Volunteers Overweight, run by Novo Nordisk A/S at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers Diabetes Mellitus, Type 2, Healthy Volunteers Overweight, Healthy Volunteers Obesity
What is being tested?: Semaglutide (administered by DV3396 pen) and Semaglutide (administered by PDS290 pen)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteNetherlands
Study dates: 28 Oct 2019to 4 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

Known or suspected hypersensitivity to trial product(s) or related products.
Previous participation in trial INS-4604 or INS-4582. Participation is defined as having received investigational product.
Female who is pregnant, breast-feeding or intends to become pregnant within 4 weeks of Day 1 or is of child-bearing potential and not using highly effective contraceptive methods.
Participation in a drug study within 60 days prior to drug administration in the current study OR participation in more than 4 other drug studies in the 12 months prior to drug administration in the current study.
Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Glycosylated hemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.

Show all 26Show fewer

Supine blood pressure at screening (after resting for 5 min or longer) outside the range of 90-160 mmHg for systolic or 45-89 mmHg for diastolic.
Supine pulse rate (as part of vital signs) outside the range of 40-100 beats/min after resting for 5 minutes or longer at screening.
Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives and occasional use of paracetamol (not allowed within 24 hours prior to drug administration), within 14 days prior to Day 1.
Diagnostic test results positive for HIV-1 or HIV-2 infection.
Diagnostic test results positive for active 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 trial 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
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 use of nicotine substitute products during the in-house period
Blood donation, plasma donation or blood draw:
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
Subjects with a history of malignant neoplasms within the past 5 years prior to screening will be excluded from the study
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 trial.
Vulnerable subject (e.g. person kept in detention) who may have an increased likelihood of being wronged or of incurring additional harm.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Novo Nordisk Investigational Site
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide B and Semaglutide D Administered sc

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.

Conditions: Healthy Volunteers Diabetes Mellitus, Type 2, Healthy Volunteers Overweight, Healthy Volunteers Obesity
Being tested: Semaglutide (administered by DV3396 pen), Semaglutide (administered by PDS290 pen)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04143945
Study group	Role	What they receive
DV3396 followed by PDS290	Experimental	The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach Receives: Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)
PDS290 followed by DV3396	Experimental	The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach Receives: Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensity of Injection Site Pain
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.
Measured: After 1 minute of each injection (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 20194 Jan 2020

First posted30 Oct 2019
Study start28 Oct 2019
Primary completion4 Jan 2020
Study completion4 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy Volunteers Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04143945
Sponsor's protocol ID: INS-4603
Other IDs: 2019-003654-83, U1111-1239-7955, 2019
Status last verified: Dec 2020
First submitted: 28 Oct 2019
Last updated: 20 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

Snitker S, Andersen A, Lindskov PS, van Marle S, Sode BF, Sparre T. Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector. Diabetes Obes Metab. 2022 Aug;24(8):1643-1646. doi: 10.1111/dom.14718. Epub 2022 May 20. No abstract available.
PubMed 35434913

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingPhase 2
A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)

All Healthy Volunteers Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide B and Semaglutide D Administered sc
ClinicalTrials.gov ID: NCT04143945
Acronym / sponsor ID: INS-4603
Conditions: Healthy Volunteers Diabetes Mellitus, Type 2, Healthy Volunteers Overweight, Healthy Volunteers Obesity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 28 Oct 2019 (actual)
Primary completion: 4 Jan 2020 (actual)
Study completion: 4 Jan 2020 (actual)
First posted: 30 Oct 2019 (actual)
Results: Posted 20 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DV3396 followed by PDS290	Experimental	Drug: Semaglutide (administered by DV3396 pen), Drug: Semaglutide (administered by PDS290 pen)The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach
PDS290 followed by DV3396	Experimental	Drug: Semaglutide (administered by DV3396 pen), Drug: Semaglutide (administered by PDS290 pen)The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (26 listed)

Known or suspected hypersensitivity to trial product(s) or related products.
Previous participation in trial INS-4604 or INS-4582. Participation is defined as having received investigational product.
Female who is pregnant, breast-feeding or intends to become pregnant within 4 weeks of Day 1 or is of child-bearing potential and not using highly effective contraceptive methods.
Participation in a drug study within 60 days prior to drug administration in the current study OR participation in more than 4 other drug studies in the 12 months prior to drug administration in the current study.
Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Semaglutide (administered by DV3396 pen)Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day	Drug	DV3396 followed by PDS290, PDS290 followed by DV3396
Semaglutide (administered by PDS290 pen)Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day	Drug	DV3396 followed by PDS290, PDS290 followed by DV3396

Primary outcome

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.

Results and safety

Results posted to the registry on 20 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A: DV3396 (Right) Then PDS290 (Left)	26	26
Sequence B: DV3396 (Left) Then PDS290 (Right)	26	26
Sequence C: PDS290 (Right) Then DV3396 (Left)	26	26
Sequence D: PDS290 (Left) Then DV3396 (Right)	26	26

Primary outcome: Intensity of Injection Site Pain

Time frame: After 1 minute of each injection (Day 1). Mean (Standard Deviation). Unit: Score on a scale

Measure	DV3396 n = 104	PDS290 n = 104
Value	8.3 (12.9)	5.7 (9.3)

DV3396 vs PDS290: Estimated treatment difference: 2.6 (95% CI 0.1 to 5.1), p = 0.0395, ANOVA

Population analysed: The per protocol (PP) set included all participants who had received both injections of semaglutide and had completed both intensity of injection site pain assessments.

Adverse events

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	0 of 104 (0%)	28 of 104 (26.9%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35434913Snitker S, Andersen A, Lindskov PS, van Marle S, Sode BF, Sparre T. Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector. Diabetes Obes Metab. 2022 Aug;24(8):1643-1646. doi: 10.1111/dom.14718. Epub 2022 May 20. No abstract available.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Healthy Volunteers Diabetes Mellitus, Type 2

Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingPhase 2
A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of Injection Site Pain (time frame: After 1 minute of each injection (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143945, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.