Comparison of injection site experience for semaglutide sc

Phase 1

• Conditions: Healthy volunteers (Diabetes Mellitus, Type 2)(Overweight)(Obesity); MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002284-10-NL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-25
• Study Completion: 2019-09-04
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

- 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
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

- 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare, in healthy subjects, the injection site 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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable