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Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01707160
First received: October 10, 2012
Last updated: October 15, 2012
Last verified: October 2012
History of Changes

October 10, 2012
October 15, 2012
November 1995
December 1995   (final data collection date for primary outcome measure)
Area under the Curve [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01707160 on ClinicalTrials.gov Archive Site
  • Maximum insulin concentration (Cmax) [ Designated as safety issue: No ]
  • Time to maximum insulin concentration (tmax) [ Designated as safety issue: No ]
  • Minimum glucose concentration (Cmin(glu)) [ Designated as safety issue: No ]
  • Time to minimum glucose concentration (tmin(glu)) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers
A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.
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
  • Healthy
  • Drug: biphasic insulin aspart 30
    One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
  • Drug: biphasic human insulin 30
    One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
  • Experimental: Treatment period 1
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic human insulin 30
  • Active Comparator: Treatment period 2
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic human insulin 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 1995
December 1995   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-smokers
  • BMI (body mass index) maximum 27 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
  • FBG (fasting blood glucose) maximum 6.0 mmol/L
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01707160
ANA/DCD/031
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Lisbeth V. Jakobsen, M.sc. Novo Nordisk
Novo Nordisk
October 2012

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