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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: semaglutide

• Registration Number: NCT00813020
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Study Start: 2009-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	semaglutide	-
B	semaglutide	-
C	semaglutide	-

Primary Outcome Measures

Name	Time	Method
AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration	a 28 day time period

Secondary Outcome Measures

Name	Time	Method
Cmax of the plasma NN9535 curve	a 28 day time period