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

NCT ID: NCT00813020

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-04-30

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses

B

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses

C

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses

Interventions

semaglutide

Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses

Intervention Type: DRUG

semaglutide

Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses

Intervention Type: DRUG

semaglutide

Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses

Intervention Type: DRUG

Other Intervention Names

NN9535

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Berlin, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2008-004990-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9535-3679

Identifier Type: -

Identifier Source: org_study_id