A TRIAL TO COMPARE THE INJECTION SITE PAIN EXPERIENCE OF 0.25 MG SEMAGLUTIDE SC ADMINISTERED BY 2 DIFFERENT PRODUCTS
- Conditions
- 10018424Overweight, obesityDiabetes
- Registration Number
- NL-OMON48226
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
- Male or female subjects, aged 18 to 75 years (both inclusive) at the time of
signing informed consent
- Body mass index (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 (ECG), and
clinical laboratory tests performed during the screening visit, as judged by
the Investigator
- 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
- Any disorder that in the Investigator's opinion might jeopardize subject's
safety, evaluation of results, or compliance with the protocol
- Glycosylated hemoglobin >=6.5% 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 (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 center
- Use of tobacco and nicotine products, defined as any of the below:
a) Smoking more than 1 cigarette or the equivalent per day on average
b) Not able or willing to refrain from smoking and the use of nicotine
substitute products during the inhouse 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Intensity of injection site pain</p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory endpoints:<br /><br>Categorical assessment of injection site pain<br /><br>More than moderate injection site pain<br /><br>Quality of pain<br /><br>Duration of pain<br /><br>Comparative pain experience<br /><br>The DV3396 product hurt less than or about the same as the PDS290 product</p><br>