Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00993096

U1111-1111-9032 (Other Identifier)

2008-008472-14 (EudraCT Number)

NN5401-3539

Details and patient eligibility

About

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

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)
• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
• 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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33 participants in 6 patient groups

IDegAsp low

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

IDegAsp middle

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

IDegAsp high

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin degludec/insulin aspart

BIAsp 30 low

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

BIAsp 30 middle

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

BIAsp 30 high

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30