Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01051102

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin degludec/insulin aspart Drug: biphasic insulin aspart 30	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDegAsp	Drug: insulin degludec/insulin aspart Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
Active Comparator: BIAsp 30	Drug: biphasic insulin aspart 30 Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Arm

Intervention/Treatment

Experimental: IDegAsp

Drug: insulin degludec/insulin aspart

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Active Comparator: BIAsp 30

Drug: biphasic insulin aspart 30

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Outcome Measures

Primary Outcome Measures

Area under the Glucose Infusion Rate curve after a single dose [From 4-12 hours]

Secondary Outcome Measures

Area under the insulin aspart concentration-time curve after a single dose [From 0-12 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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