We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623375
First Posted: June 20, 2012
Last Update Posted: February 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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: insulin degludec Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the serum insulin degludec concentration-of s.c. administration [ Time Frame: From 0 to infinity after single dose ]
  • Area under the serum insulin degludec concentration-of i.v. administration [ Time Frame: From 0 to infinity after single dose ]

Secondary Outcome Measures:
  • Terminal half-life for insulin degludec [ Time Frame: From 0 to 30 hours after single dose ]
  • Volume of distribution of insulin degludec, estimated during the terminal phase [ Time Frame: From 0 to 30 hours after single dose ]

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: insulin degludec
A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).
Experimental: i.v. Drug: insulin degludec
A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).
Other Name: IDeg

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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 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
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): NCT01623375


Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01623375     History of Changes
Other Study ID Numbers: NN1250-4000
2012-000078-50 ( EudraCT Number )
U1111-1126-8860 ( Other Identifier: WHO )
First Submitted: June 4, 2012
First Posted: June 20, 2012
Last Update Posted: February 19, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs