A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00813020

NN9535-3679

2008-004990-17 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.

Enrollment

44 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator
Body weight between 80 kg and 110 kg (both inclusive)
Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive
Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)

Exclusion criteria

Known or suspected allergy to trial product(s) or related products
Previous participation in this trial (randomisation)
The receipt of any investigational medicinal product within 3 months prior to this trial
Subjects who have had a clinically relevant illness within 4 weeks of dosing
History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period