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Completed

NCT Number: NCT01464099

Bioequivalence of Two NovoLog® Formulations 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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

Drug

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

Primary outcomes

  1. Area under the insulin aspart bolus concentration-time curve

    Time frame: From 0 and up to 12 hours post bolus dose administration

  2. Maximum plasma concentration (Cmax) of insulin aspart

    Time frame: From 0 and up to 12 hours post bolus dose administration

Secondary outcomes

  1. Time to maximum concentration (Tmax) of insulin aspart

    Time frame: From 0-12 hours post bolus dose administration

  2. AUC (area under the curve) of insulin aspart

    Time frame: From -4 to 0 hours after dose administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 3, 2011
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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