Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051102
• Other study ID #: NN5401-1983
• Secondary ID: U1111-1112-3698
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2010
• Last updated: February 9, 2017
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec/insulin aspart
Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
• biphasic insulin aspart 30
Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Ikushima I, Hirao K, Sasaki T, Fumiaki K, Clauson P, Roepstorff C, Haahr HL. Glucose lowering effect of IDegAsp in Japanese subjects with type 1 diabetes. 56th Annual Meeting of the Japan Diabetes Society (JDS) 2013; Country: Japan City: Kumamoto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Glucose Infusion Rate curve after a single dose		From 4-12 hours
Secondary	Area under the insulin aspart concentration-time curve after a single dose		From 0-12 hours

External Links

•   Clinical Trials at Novo Nordisk