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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464099

ANA-3501

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Insulin aspart 100U/mL

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin aspart

Insulin aspart 200U/mL

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin aspart