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

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 1

Intervention: insulin aspart (Drug); insulin aspart (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
DJ Chatterjee, Study Director, Affiliation: Novo Nordisk A/S

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Area under the insulin aspart bolus concentration-time curve

Maximum plasma concentration (Cmax) of insulin aspart

Secondary outcome:

Time to maximum concentration (Tmax) of insulin aspart

AUC (area under the curve) of insulin aspart

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Novo Nordisk Clinical Trial Call Center, Chula Vista, California 91911, United States

Clinical Trials at Novo Nordisk

Starting date: June 2008
Last updated: November 2, 2011