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A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01623375
First received: June 4, 2012
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.


Condition Intervention Phase
Diabetes
Healthy
 Drug: IDeg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the serum insulin degludec concentration-of s.c. administration [ Time Frame: From 0 to infinity after single dose ] [ Designated as safety issue: No ]
  • Area under the serum insulin degludec concentration-of i.v. administration [ Time Frame: From 0 to infinity after single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Terminal half-life for insulin degludec [ Time Frame: From 0 to 30 hours after single dose ] [ Designated as safety issue: No ]
  • Volume of distribution of insulin degludec, estimated during the terminal phase [ Time Frame: From 0 to 30 hours after single dose ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: s.c. Drug: IDeg
A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).
Experimental: i.v. Drug: IDeg
A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
  • Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623375

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Hanne Hastrup-Nielsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01623375     History of Changes
Other Study ID Numbers: NN1250-4000, 2012-000078-50, U1111-1126-8860
Study First Received: June 4, 2012
Last Updated: April 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 23, 2013