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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01296438
First received: February 14, 2011
Last updated: June 29, 2012
Last verified: June 2012

February 14, 2011
June 29, 2012
February 2011
March 2011   (final data collection date for primary outcome measure)
Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0-1 hour after trial drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01296438 on ClinicalTrials.gov Archive Site
Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0-12 hours after trial drug administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1
A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin aspart.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: NN1218
    Single dose of 0.2 U/kg body weight NN1218 injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin)
  • Drug: insulin aspart
    Single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight NN1218 injected subcutaneously (under the skin)
  • Experimental: Treatment sequence 1
    Intervention: Drug: NN1218
  • Active Comparator: Treatment sequence 2
    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
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 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:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01296438
NN1218-3872, 2010-022222-33, U1111-1118-6955
No
Public Access to Clinical Trials, 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