Comparison of Two NN1250 Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00966368
First received: August 25, 2009
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.


Condition Intervention Phase
Diabetes
Healthy
Drug: insulin degludec
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 Trial to Test for Bioequivalence Between Two NN1250 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 Insulin Degludec concentration-time curve from 0 to 120 hours after single dose [ Time Frame: From 0 to 120 hours after dosing ] [ Designated as safety issue: No ]
  • Maximum observed Insulin Degludec concentration after single dose [ Time Frame: From 0 to 120 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum observed Insulin Degludec concentration after single dose [ Time Frame: From 0 to 120 hours after dosing ] [ Designated as safety issue: No ]
  • Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose [ Time Frame: From 0-24 hours after dosing ] [ Designated as safety issue: No ]
  • Terminal half-life for Insulin Degludec [ Time Frame: From 0 to 120 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg E Drug: insulin degludec
Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)
Experimental: IDeg M Drug: insulin degludec
Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)

  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, 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
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: NCT00966368

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911-1350
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: D. J. Chatterjee, PhD. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00966368     History of Changes
Other Study ID Numbers: NN1250-1988, U1111-1122-2992, 2011-002949-35, P/44/2010, P/96/2011
Study First Received: August 25, 2009
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014