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

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ClinicalTrials.gov Identifier: NCT00813020
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
Experimental: B Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
Experimental: C Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
Other Name: NN9535


Outcome Measures
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Primary Outcome Measures :
  1. AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration [ Time Frame: a 28 day time period ]

Secondary Outcome Measures :
  1. Cmax of the plasma NN9535 curve [ Time Frame: a 28 day time period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813020


Locations
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Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00813020    
Other Study ID Numbers: NN9535-3679
2008-004990-17 ( EudraCT Number )
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases