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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464099
First Posted: November 3, 2011
Last Update Posted: October 28, 2016
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
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin aspart Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the insulin aspart bolus concentration-time curve [ Time Frame: From 0 and up to 12 hours post bolus dose administration ]
  • Maximum plasma concentration (Cmax) of insulin aspart [ Time Frame: From 0 and up to 12 hours post bolus dose administration ]

Secondary Outcome Measures:
  • Time to maximum concentration (Tmax) of insulin aspart [ Time Frame: From 0-12 hours post bolus dose administration ]
  • AUC (area under the curve) of insulin aspart [ Time Frame: From -4 to 0 hours after dose administration ]

Enrollment: 24
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin aspart 100U/mL 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
Experimental: Insulin aspart 200U/mL 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464099


Locations
United States, California
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01464099     History of Changes
Other Study ID Numbers: ANA-3501
First Submitted: October 31, 2011
First Posted: November 3, 2011
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs