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A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01455142
First received: October 17, 2011
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: IDegAsp
 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 NN1045 and NN5401 in Subjects With Type 1 Diabetes

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-time curve [ Time Frame: From 0 to 120 hours after single-dose (SD) ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin degludec concentration [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ] [ Designated as safety issue: No ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: After single-dose (within 0 to 12 hours after dosing) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve [ Time Frame: From 0 to 26 hours after single-dose ] [ Designated as safety issue: No ]
  • Maximum glucose infusion rate [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Drug: IDegAsp
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Experimental: Formulation 2 Drug: IDegAsp
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
  • Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
  • HbA1c below or equal to 9.5% by central laboratory analysis

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: NCT01455142

Locations
Austria
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Kirstine Stender-Petersen 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: NCT01455142     History of Changes
Other Study ID Numbers: NN1045-3834, 2011-001569-42, U1111-1120-3922
Study First Received: October 17, 2011
Last Updated: June 28, 2012
Health Authority: Austria: Austrian Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013