Healthy Volunteers Diabetes Mellitus, Type 2, Healthy Volunteers Obesity, Healthy Volunteers Overweight
Conditions
Brief 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.
Interventions
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
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Injection Site Pain | 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. |
Countries
Netherlands
Participant flow
Recruitment details
The trial was conducted at one site in the Netherlands.
Pre-assignment details
Participants were randomised in a 2×2 scheme evenly to 4 sequences (A, B, C and D) of either DV3396 or PDS290 and side of injection (right/left) on abdomen.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants 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. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 2 (Day 1) | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 40.9 Years STANDARD_DEVIATION 18.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Asian + Black or African American | 0 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islan | 0 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 98 participants |
| Race/Ethnicity, Customized White + Asian | 2 participants |
| Race/Ethnicity, Customized White + Black or African American | 0 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 103 |
| other Total, other adverse events | 15 / 103 |
| serious Total, serious adverse events | 0 / 103 |
Outcome results
Primary
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.
Time frame: After 1 minute of each injection (Day 1)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DV3396 | Intensity of Injection Site Pain | 35.1 score on a scale | Standard Deviation 23.1 |
| PDS290 | Intensity of Injection Site Pain | 4.4 score on a scale | Standard Deviation 7.5 |
Comparison: The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.p-value: <0.000195% CI: [26.6, 34.8]ANOVA