Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk A/S27 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin degludecDRUG

Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).

insulin degludec/insulin aspartDRUG

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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). * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Locations (1)

Unnamed facility

Neuss, Germany

Outcomes

Primary Outcomes

Area under the glucose infusion rate curve

Time frame: From 0 to 6 hours after single-dose (only for IDeg and IDegAsp)

Area under the glucose infusion rate curve

Time frame: From 6 to 24 hours after single-dose (only for IDegAsp and IAsp)

Secondary Outcomes

Area under the serum insulin degludec concentration-time curve

Time frame: From 0 to 120 hours after single-dose (only for IDeg and IDegAsp)

Area under the serum insulin aspart concentration-time curve

Time frame: From 0 to 12 hours after single-dose (only for IDegAsp and IAsp)

Data from ClinicalTrials.gov

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