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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813020
• Other study ID #: NN9535-3679
• Secondary ID: 2008-004990-17
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: February 20, 2015
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: February 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
• semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
• semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cmax of the plasma NN9535 curve		a 28 day time period	No

External Links

•   Clinical Trials at Novo Nordisk