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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01464099
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: November 2011
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464099

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: DJ Chatterjee Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01464099     History of Changes
Other Study ID Numbers: ANA-3501
Study First Received: October 31, 2011
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014