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CompletedNCT01051102Updated Feb 10, 2017

Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

A Phase 1 interventional study of insulin degludec/insulin aspart and biphasic insulin aspart 30 in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 21 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    IDegAsp

    Drug: insulin degludec/insulin aspart

  • Active comparator
    BIAsp 30

    Drug: biphasic insulin aspart 30

Interventions

  • Druginsulin degludec/insulin aspart

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

  • Drugbiphasic insulin aspart 30

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

06

What researchers measure

Primary outcomes

  1. Area under the Glucose Infusion Rate curve after a single dose

    Time frame: From 4-12 hours

Secondary outcomes

  1. Area under the insulin aspart concentration-time curve after a single dose

    Time frame: From 0-12 hours

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 130-0004, Japan
08

References and documents

Publications

  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01051102
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 18, 2010
Start date
Jan 2010
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Feb 10, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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