The purpose of this study is to investigate if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 2 different products, semaglutide and dulaglutide, in healthy volunteers. The 2 products…
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
Background summary
People with diabetes have too much sugar in their blood and need treatment to
control their sugar level. Semaglutide and dulaglutide are approved medicines
that help to lower blood sugar levels in patients with type 2 diabetes.
Semaglutide and dulaglutide are injected under the skin with an injection pen.
In this study the pain experience around the injection site will be compared
after administration of semaglutide and dulaglutide in 2 different injection
pens.
Study objective
The purpose of this study is to investigate if there is a difference in the
injection site pain experience after an injection under the skin (subcutaneous)
with 2 different products, semaglutide and dulaglutide, in healthy volunteers.
The 2 products will be injected with 2 different injection pens.
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) and dulaglutide (0.75 mg) will be given as injections
under the skin of the belly. After each injection subjects are asked to fill in
questionnaires about the level and type of pain they may experience around the
injection site during and after the injection.
Study burden and risks
Semaglutide
Semaglutide has been extensively studied in healthy volunteers. diabetic and
obese patients. The following side effects are very common (may affect more
than 1 in 10 people ):
• feeling sick (*nausea*)
• diarrhea (loose, watery and more frequent stools)
These side effects most often happen at the start of the treatment and are
usually mild to moderate in severity
Dulaglutide
The study compound may cause side effects.
The following side effects are very common (may affect more than 1 in 10
people):
• feeling sick (*nausea*)
• being sick (*vomiting*)
• diarrhea (loose, watery and more frequent stools)
• abdominal (stomach) pain
These side effects are usually not severe. They are most common when first
starting dulaglutide but decrease over time in most subjects.
The study compounds may also have side effect 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 chest) will be pasted at specific
locations on the 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, aged 18-75 years (both inclusive) at the time of signing
informed consent.
- Body mass index >=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.
- Any disorder which in the Investigator*s opinion might jeopardise subject*s
safety, evaluation of results, or compliance with the protocol.
- Glycosylated hemoglobin (HbA1c) >= 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 Day 1.
- 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:
o Smoking more than 1 cigarette or the equivalent per day on average.
o Not able or willing to refrain from smoking and 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
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-83003844--NL |
| CCMO | NL71900.056.19 |