A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin degludec/insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455142

2011-001569-42 (EudraCT Number)

U1111-1120-3922 (Other Identifier)

NN1045-3834

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.

Enrollment: 32 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
• Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
• HbA1c below or equal to 9.5% by central laboratory analysis

Exclusion criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Formulation 1

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Formulation 2

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart