Healthy volunteers (Diabetes Mellitus, Type 2) (Overweight) (Obesity) MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutr
Conditions
Interventions
Product Name: Semaglutide D 0.5mg/mL DV3396
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SEMAGLUTIDE
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration unit:
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. - Body mass index 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: - 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. - 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. - 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: - 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 - 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare, in healthy subjects, the injection site pain experience of a single dose of 0.25 mg semaglutide subcutaneously (sc) given as the DV3396 product, to that of the PDS290 product.;Secondary Objective: Not applicable;Primary end point(s): Intensity of injection site pain;Timepoint(s) of evaluation of this end point: 1 min after each injection (Day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed