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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 A/S
ClinicalTrials.gov Identifier:
NCT01455142
First received: October 17, 2011
Last updated: June 28, 2012
Last verified: June 2012

October 17, 2011
June 28, 2012
October 2011
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01455142 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 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 1
    Intervention: Drug: IDegAsp
  • Experimental: Formulation 2
    Intervention: Drug: IDegAsp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01455142
NN1045-3834, 2011-001569-42, U1111-1120-3922
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Kirstine Stender-Petersen Novo Nordisk A/S
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP