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Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01707160
First received: October 10, 2012
Last updated: January 3, 2017
Last verified: January 2017
October 10, 2012
January 3, 2017
November 1995
December 1995   (Final data collection date for primary outcome measure)
Area under the Curve
Same as current
Complete list of historical versions of study NCT01707160 on ClinicalTrials.gov Archive Site
  • Maximum insulin concentration (Cmax)
  • Time to maximum insulin concentration (tmax)
  • Minimum glucose concentration (Cmin(glu))
  • Time to minimum glucose concentration (tmin(glu))
  • Adverse events
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Jacobsen LV, Søgaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403.

*   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
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01707160
ANA/DCD/031
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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