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A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01469143
First received: November 8, 2011
Last updated: January 13, 2012
Last verified: January 2012

November 8, 2011
January 13, 2012
November 2011
January 2012   (final data collection date for primary outcome measure)
Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 1 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01469143 on ClinicalTrials.gov Archive Site
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: From 0 to 12 hours ] [ Designated as safety issue: No ]
  • Time to maximum observed serum insulin aspart concentration [ Time Frame: From 0 to 12 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: NN1218
    Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
  • Drug: insulin aspart
    At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
  • Experimental: NN1218
    Intervention: Drug: NN1218
  • Active Comparator: insulin aspart
    Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
  • Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Subjects 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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01469143
NN1218-3977, 2011-004081-15, U1111-1123-6692
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Nanna Marie Lind, DVM PhD Novo Nordisk A/S
Novo Nordisk A/S
January 2012

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