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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Summary

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.

Clinical Details

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

Eligibility

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

Locations and Contacts

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

Clinical Trials at Novo Nordisk

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

Page last updated: August 23, 2015

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