A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: Faster-acting insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01469143

2011-004081-15 (EudraCT Number)

NN1218-3977

U1111-1123-6692 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.

Enrollment: 40 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus for more than 12 months
• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
• Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)

Exclusion criteria

• Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
• 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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40 participants in 2 patient groups

NN1218

Experimental group

Treatment:

Drug: Faster-acting insulin aspart

insulin aspart

Active Comparator group

Treatment:

Drug: insulin aspart