The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intensity of injection site pain
Secondary outcome
Exploratory endpoints:
Categorical assessment of injection site pain
More than moderate injection site pain
Quality of pain
Duration of pain
Comparative pain experience
The DV3396 product hurt less than or about the same as the PDS290 product
Background summary
People with diabetes have high amounts of sugar in their blood and need
treatment to control their sugar level. Semaglutide is a newly approved
antidiabetic medicine that helps to lower blood sugar levels in patients with
type 2 diabetes. Semaglutide is injected under the skin. Semaglutide is
injected under the skin with a, so called, injection pen. In this study the
pain around the injection site will be compared after administration of 2
different solutions of semaglutide. Both injection pens will contain the same
amount of semaglutide, but the fluid in which the drug is dissolved in is
different.
Study objective
The primary objective is to compare, in healthy subjects, the injection site
experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396
product to that of the PDS290 product.
Study design
The actual study will consist of 1 day during which the subjects will stay in
the research center for about 6 hours.
Intervention
Semaglutide (0.25 mg) will be given twice as an injection under the skin
(subcutaneous), once on the left side and once on the right side of the belly.
There will be a minimum of 30 minutes between the 2 injections. After each
injection the subjects are asked to fill in questionnaires about the level of
pain they experience around the injection site after the injection (so not the
pain of the injection itself).
During the 30 minutes after each administration of the study compound the
subjects should stay in bed or should be seated in a chair, and not walk around.
The subjects are blindfolded during the administration of the study compound so
they cannot see which injection pen was used. Only the person who will inject
will know which pen was used on which side of the belly. The person who will
give the questionnaires also does not know which injection pen was used.
Study burden and risks
The study compound may cause side effects.
The following side effects are most frequently observed (in more than 1 out of
10 people):
Stomach and gut problems. Signs may include:
•feeling sick (*nausea*) or being sick (*vomiting*)
•diarrhea (loose, watery and more frequent stoo ls)
•upset stomach and constipation
•Low appetite
•Pain in your stomach area
The study compound may also have side effects that are still unknown.
Drawing blood may be painful or cause some bruising. In total, we will take
about 40 milliliters (mL) of blood. To make a heart tracing, electrodes (small,
plastic pat ches) will be pasted at specific locations on your arms, chest and
legs. Prolonged use of these
electrodes can cause skin irritation (rash and itching).
Novo Allé
Bagsværd 2880
DK
Novo Allé
Bagsværd 2880
DK
Listed location countries
Age
Inclusion criteria
- Male or female subjects, aged 18 to 75 years (both inclusive) at the time of
signing informed consent.
- Body mass index (BMI) >=25.0 kg/m2.
- 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
- Female who is pregnant, breast-feeding or intends to become pregnant within 4
weeks of Day 1 or is of childbearing potential and not using highly effective
contraceptive methods with her fertile male sexual partner.
- Any disorder that in the Investigator*s opinion might jeopardize 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.
- 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 drug administration.
- 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 the use of nicotine
substitute products during the in-house period
- Subject is not able to understand and read English or Dutch, or subject is
not able to understand and comply with the study requirements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003654-83-NL |
| CCMO | NL71621.056.19 |