A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134224

2009-015646-30 (EudraCT Number)

U1111-1113-7056 (Other Identifier)

NN5401-1978

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index below or equal to 35.0 kg/m^2

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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39 participants in 6 patient groups

NN5401 - low dose

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

NN5401 - medium dose

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

NN5401 - high dose

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

biphasic insulin aspart 30 - low dose

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

biphasic insulin aspart 30 - medium dose

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

biphasic insulin aspart 30 - high dose

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30