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A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01134224
First received: May 27, 2010
Last updated: June 28, 2012
Last verified: April 2012
History of Changes

May 27, 2010
June 28, 2012
May 2010
November 2010   (final data collection date for primary outcome measure)
Area under the glucose infusion rate curve (only for NN5401) [ Time Frame: from 0 to 24 hours after single-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01134224 on ClinicalTrials.gov Archive Site
  • Area under the insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose administration ] [ Designated as safety issue: No ]
  • Area under the insulin aspart concentration-time curve (only for BIAsp 30) [ Time Frame: from 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 in subjects with type 2 diabetes.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: NN5401
    0.4 U/kg body weight injected subcutaneously (under the skin) once
  • Drug: NN5401
    0.6 U/kg body weight injected subcutaneously (under the skin) once
  • Drug: NN5401
    0.8 U/kg body weight injected subcutaneously (under the skin) once
  • Drug: biphasic insulin aspart 30
    0.4 U/kg body weight injected subcutaneously (under the skin) once
  • Drug: biphasic insulin aspart 30
    0.6 U/kg body weight injected subcutaneously (under the skin) once
  • Drug: biphasic insulin aspart 30
    0.8 U/kg body weight injected subcutaneously (under the skin) once
  • Experimental: NN5401 - low dose
    Intervention: Drug: NN5401
  • Experimental: NN5401 - medium dose
    Intervention: Drug: NN5401
  • Experimental: NN5401 - high dose
    Intervention: Drug: NN5401
  • Active Comparator: biphasic insulin aspart 30 - low dose
    Intervention: Drug: biphasic insulin aspart 30
  • Active Comparator: biphasic insulin aspart 30 - medium dose
    Intervention: Drug: biphasic insulin aspart 30
  • Active Comparator: biphasic insulin aspart 30 - high dose
    Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus for at least 12 months
  • Body Mass Index (BMI) below or equal to 35.0 kg/m2

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 start
  • 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01134224
NN5401-1978, U1111-1113-7056, 2009-015646-30
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Marianne Thrane, PhD Novo Nordisk
Novo Nordisk
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP