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Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00993096
First received: October 8, 2009
Last updated: June 28, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the pharmacodynamic dose-response relationship of NN5401 at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: NN5401
Drug: biphasic insulin aspart 30
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area (AUC) under the glucose infusion rate curve [ Time Frame: from 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area (AUC) under the insulin aspart concentration time curve [ Time Frame: from 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN5401
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Experimental: B Drug: NN5401
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Experimental: C Drug: NN5401
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Active Comparator: D Drug: biphasic insulin aspart 30
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Active Comparator: E Drug: biphasic insulin aspart 30
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Active Comparator: F Drug: biphasic insulin aspart 30
Single dose of 0.8 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 for at least 12 months
  • Body mass index (BMI): 18.0-28.0 kg/m2 (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 trial entry
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993096

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Birgitte Esmarck Meibom, MSC.PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00993096     History of Changes
Other Study ID Numbers: NN5401-3539, 2008-008472-14, U1111-1111-9032
Study First Received: October 8, 2009
Last Updated: June 28, 2012
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
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013