A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01121276

2009-017627-25 (EudraCT Number)

NN1218-3824

U1111-1113-6897 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes mellitus for more than 12 months
• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
• Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)

Exclusion criteria

• Surgery or trauma with significant blood loss (more than 500 mL) within the last 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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82 participants in 5 patient groups

NN1218, formulation A

Experimental group

Treatment:

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

NN1218, formulation B

Experimental group

Treatment:

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

NN1218, formulation C

Experimental group

Treatment:

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

NN1218, formulation D

Experimental group

Treatment:

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

Drug: Faster-acting insulin aspart

insulin aspart

Active Comparator group

Treatment:

Drug: insulin aspart