A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: June 4, 2010
Last updated: September 24, 2015
Last verified: September 2015
This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin degludec/insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults 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 serum insulin degludec concentration-time curve [ Time Frame: from 0 to infinity after single-dose ] [ Designated as safety issue: No ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed [ Time Frame: from 0 to 57 hours after single-dose ] [ Designated as safety issue: No ]
  • Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed [ Time Frame: from 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN5401 Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).


Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2

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
  • Not able or willing to refrain from smoking during the inpatient period
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01138488

Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01138488     History of Changes
Other Study ID Numbers: NN5401-1982  U1111-1113-6874  2009-016779-31 
Study First Received: June 4, 2010
Last Updated: September 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 01, 2016