Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00992537
First received: October 8, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in 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 [ Time Frame: From 0 to 6 hours after single-dose administration ] [ Designated as safety issue: No ]
  • Area under the glucose infusion rate curve [ Time Frame: From 4 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single-dose administration ] [ Designated as safety issue: No ]
  • Maximum observed insulin degludec concentration [ Time Frame: From 0 to 120 hours after single-dose administration ] [ Designated as safety issue: No ]
  • Area under the insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours after single-dose administration ] [ Designated as safety issue: No ]
  • Maximum observed insulin aspart concentration [ Time Frame: 0-12 hours after single-dose administration ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Drug: insulin degludec
Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Experimental: IDegAsp Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Active Comparator: IAsp Drug: insulin aspart
Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

  Eligibility

Ages Eligible for Study:   18 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 18.0-28.0 kg/m^2 (both inclusive)

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
  • Smoker (defined as a subject who is smoking more than 5 cigarettes 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
  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: NCT00992537

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00992537     History of Changes
Other Study ID Numbers: NN5401-1977, 2008-008357-32, U1111-1111-9043
Study First Received: October 8, 2009
Last Updated: November 26, 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 aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014