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Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01464099
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: November 2011
History of Changes

October 31, 2011
November 2, 2011
June 2008
November 2008   (final data collection date for primary outcome measure)
  • Area under the insulin aspart bolus concentration-time curve [ Time Frame: From 0 and up to 12 hours post bolus dose administration ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of insulin aspart [ Time Frame: From 0 and up to 12 hours post bolus dose administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01464099 on ClinicalTrials.gov Archive Site
  • Time to maximum concentration (Tmax) of insulin aspart [ Time Frame: From 0-12 hours post bolus dose administration ] [ Designated as safety issue: No ]
  • AUC (area under the curve) of insulin aspart [ Time Frame: From -4 to 0 hours after dose administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
A Single Center, Randomized, Double-blind, Balanced Two-period Cross-over Trial to Test for Bioequivalence Between a Marketed NovoLog® Formulation Containing 100 U/mL Versus a New NovoLog® Formulation Containing 200 U/mL in a Combined Regimen of a Continuous Subcutaneous Infusion and a Meal-time Bolus in Subjects With Type 1 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
Drug: insulin aspart
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
  • Active Comparator: Insulin aspart 100U/mL
    Intervention: Drug: insulin aspart
  • Experimental: Insulin aspart 200U/mL
    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
24
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 1 diabetes treated with insulin for at least 12 months
  • BMI (Body Mass Index) between 18.0-29.0 kg/m^2
  • Negative fasting C-peptide (below or equal to 0.6 ng/mL)
  • HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
  • Current treatment with insulin below or equal to 1.2 U/kg/day
  • Subject should be in good health based on medical history, physical examination and routine laboratory data

Exclusion Criteria:

  • Any known/suspected allergies to trial medication or similar products/devices
  • A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
  • Clinically significant active disease of any kind
  • Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
  • Blood donation (more than 500 mL) within the previous 9 weeks
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464099
ANA-3501
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: DJ Chatterjee Novo Nordisk
Novo Nordisk
November 2011

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