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
Condition: Healthy Volunteers Diabetes Mellitus, Type 2; Healthy Volunteers Overweight; Healthy Volunteers Obesity
MeSH terms: Obesity; Overweight; Diabetes Mellitus, Type 2
Intervention: Semaglutide (administered by DV3396 pen); Semaglutide (administered by PDS290 pen)
Intervention description: Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day; Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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 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.

          -  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.