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

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ClinicalTrials.gov Identifier: NCT01138488
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
HNEC TEST
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin degludec/insulin aspart Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults With Type 1 Diabetes
Study Start Date : June 2010
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NN5401 Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).



Primary Outcome Measures :
  1. Area under the serum insulin degludec concentration-time curve [ Time Frame: from 0 to infinity after single-dose ]
  2. Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose ]

Secondary Outcome Measures :
  1. Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed [ Time Frame: from 0 to 57 hours after single-dose ]
  2. Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed [ Time Frame: from 0 to 12 hours after single-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138488


Locations
Germany
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
HNEC TEST
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01138488     History of Changes
Other Study ID Numbers: NN5401-1982
U1111-1113-6874 ( Other Identifier: WHO )
2009-016779-31 ( EudraCT Number )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 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 degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs