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Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 15, 2010
Last updated: February 9, 2017
Last verified: February 2017
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 Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Glucose Infusion Rate curve after a single dose [ Time Frame: From 4-12 hours ]

Secondary Outcome Measures:
  • Area under the insulin aspart concentration-time curve after a single dose [ Time Frame: From 0-12 hours ]

Enrollment: 21
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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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Please refer to this study by its identifier: NCT01051102

Novo Nordisk Investigational Site
Tokyo, Japan, 130-0004
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT01051102     History of Changes
Other Study ID Numbers: NN5401-1983
U1111-1112-3698 ( Other Identifier: WHO )
Study First Received: January 15, 2010
Last Updated: February 9, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin, Isophane
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 22, 2017