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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00813020
First received: December 19, 2008
Last updated: July 5, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NN9535
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of the plasma NN9535 curve [ Time Frame: a 28 day time period ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN9535
Comparison of different formulations of the drug, NN9535: Formulation 1 administered in equimolar doses
Other Name: Once weekly GLP-1
Experimental: B Drug: NN9535
Comparison of different formulations of the drug, NN9535: Formulation 2 administered in equimolar doses
Experimental: C Drug: NN9535
Comparison of different formulations of the drug, NN9535: Formulation 3 administered in equimolar doses

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813020

Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tine Aggerholm Bækdal, MSC Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00813020     History of Changes
Other Study ID Numbers: NN9535-3679, 2008-004990-17
Study First Received: December 19, 2008
Last Updated: July 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014