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A Trial Investigating 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:
NCT01121289
First received: May 10, 2010
Last updated: December 9, 2013
Last verified: December 2013

May 10, 2010
December 9, 2013
April 2010
July 2010   (final data collection date for primary outcome measure)
Area under the serum NN1218 concentration-time curve [ Time Frame: From 0-1 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01121289 on ClinicalTrials.gov Archive Site
Area under the serum NN1218 concentration-time curve [ Time Frame: From 0-10 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating NN1218 in Subjects With Type 1 Diabetes
A 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 absorption and effect in the body of NN1218 in subjects with type 1 diabetes.

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
    0.2 U/kg body weight injected subcutaneously (under the skin)
  • Drug: insulin aspart
    0.2 U/kg body weight injected subcutaneously (under the skin)
  • Drug: NN1218
    0.4 U/kg body weight injected subcutaneously (under the skin)
  • Experimental: NN1218, formulation A
    Intervention: Drug: NN1218
  • Experimental: NN1218, formulation B
    Intervention: Drug: NN1218
  • Experimental: NN1218, formulation B (high)
    Intervention: Drug: NN1218
  • Experimental: NN1218, formulation C
    Intervention: Drug: NN1218
  • Experimental: NN1218, formulation D
    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
26
July 2010
July 2010   (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/m2 (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
 
NCT01121289
NN1218-3808, U1111-1113-6955, 2009-017121-19
No
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
December 2013

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