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A Comparison Between Two Formulations of NN5401 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125553
First Posted: May 18, 2010
Last Update Posted: September 25, 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 the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

Condition Intervention Phase
Diabetes Healthy Drug: insulin degludec/insulin aspart Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial to Test for Bioequivalence Between Two NN5401 Formulations 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-time curve [ Time Frame: from 0 to 120 hours after single-dose ]
  • Maximum observed serum insulin degludec concentration [ Time Frame: from 0 to 120 hours after single-dose ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: from 0 to 12 hours after single-dose ]

Secondary Outcome Measures:
  • Time to maximum observed serum insulin degludec concentration [ Time Frame: from 0 to 120 hours after single-dose ]
  • Time to maximum observed serum insulin aspart concentration [ Time Frame: from 0 to 12 hours after single-dose ]

Enrollment: 26
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp B Drug: insulin degludec/insulin aspart
Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).
Experimental: IDegAsp F Drug: insulin degludec/insulin aspart
Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).

  Eligibility

Information from the National Library of Medicine

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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, vital signs and electrocardiogram (ECG), as judged by the physician
  • Body mass index between 18.0 and 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 trial start
  • 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): NCT01125553


Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
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: NCT01125553     History of Changes
Other Study ID Numbers: NN5401-1980
U1111-1113-7011 ( Other Identifier: WHO )
First Submitted: May 7, 2010
First Posted: May 18, 2010
Last Update Posted: September 25, 2015
Last Verified: September 2015

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