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A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02033239
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

January 9, 2014
January 10, 2014
January 18, 2017
January 2014
June 2014   (Final data collection date for primary outcome measure)
Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ]
Same as current
Complete list of historical versions of study NCT02033239 on ClinicalTrials.gov Archive Site
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours ]
  • Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: Within 0 to 12 hours after dosing ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.
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
    Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
  • Drug: insulin aspart
    Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
  • Experimental: FIAsp
    Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
    Intervention: Drug: Faster-acting insulin aspart
  • Active Comparator: NovoRapid®
    Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
    Intervention: Drug: insulin aspart

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Same as current
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.5-28.0 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 screening
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02033239
NN1218-3887
2011-001580-41 ( EudraCT Number )
U1111-1120-3772 ( 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
January 2017

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