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A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455142
First Posted: October 19, 2011
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial to Test for Bioequivalence Between NN1045 and NN5401 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 serum insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single-dose (SD) ]
  • Maximum observed serum insulin degludec concentration [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours after single-dose ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: After single-dose (within 0 to 12 hours after dosing) ]

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve [ Time Frame: From 0 to 26 hours after single-dose ]
  • Maximum glucose infusion rate [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ]

Enrollment: 32
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Drug: insulin degludec/insulin aspart
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other Name: IDegAsp
Experimental: Formulation 2 Drug: insulin degludec/insulin aspart
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other Name: IDegAsp

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
  • Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
  • HbA1c below or equal to 9.5% by central laboratory analysis

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
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): NCT01455142


Locations
Austria
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01455142     History of Changes
Other Study ID Numbers: NN1045-3834
2011-001569-42 ( EudraCT Number )
U1111-1120-3922 ( Other Identifier: WHO )
First Submitted: October 17, 2011
First Posted: October 19, 2011
Last Update Posted: February 23, 2015
Last Verified: February 2015

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