A Trial Investigating the Total Exposure of NN5401 in Children, Adolescents and Adult Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01138488
First received: June 4, 2010
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

This trial is conducted in Europe. The aim of this study is 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
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 observed [ Time Frame: from 0 to 57 hours after single-dose ] [ Designated as safety issue: No ]
  • Maximum observed insulin aspart concentration of NN5401 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).

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138488

Locations
Germany
Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Charlotte L. Adrian Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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: October 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014