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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464099
• Other study ID #: ANA-3501
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2011
• Last updated: October 26, 2016
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin aspart bolus concentration-time curve		From 0 and up to 12 hours post bolus dose administration	No
Primary	Maximum plasma concentration (Cmax) of insulin aspart		From 0 and up to 12 hours post bolus dose administration	No
Secondary	Time to maximum concentration (Tmax) of insulin aspart		From 0-12 hours post bolus dose administration	No
Secondary	AUC (area under the curve) of insulin aspart		From -4 to 0 hours after dose administration	No

External Links

•   Clinical Trials at Novo Nordisk