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

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ClinicalTrials.gov Identifier: NCT01623375
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin degludec Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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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

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

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 Posted: June 20, 2012    Key Record Dates
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