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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296438
First Posted: February 15, 2011
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
February 14, 2011
February 15, 2011
February 23, 2015
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 ]
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 ]
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: Faster-acting insulin aspart
    Single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin)
    Other Name: NN1218
  • 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 faster-acting insulin aspart injected subcutaneously (under the skin)
  • Experimental: Treatment sequence 1
    Intervention: Drug: Faster-acting insulin aspart
  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01296438
NN1218-3872
2010-022222-33 ( EudraCT Number )
U1111-1118-6955 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2015

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