This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01697618
First received: September 28, 2012
Last updated: January 3, 2017
Last verified: January 2017
September 28, 2012
January 3, 2017
April 1997
November 1998   (Final data collection date for primary outcome measure)
Area under the serum insulin curve
Same as current
Complete list of historical versions of study NCT01697618 on ClinicalTrials.gov Archive Site
  • Overall shape of the 24 hour serum insulin profile
  • Cmax (maximum plasma concentration)
  • tmax (time to reach maximum)
  • Area under the curve following each injections derived from 24 hours serum insulin profiles
  • Overall shape of the 24 hour serum glucose profile
  • Serum glucose excursions (EXC)
Same as current
Not Provided
Not Provided
 
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients
This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart 30
    Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
  • Drug: biphasic human insulin 30
    Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
  • Experimental: BIAsp 30
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic human insulin 30
  • Active Comparator: BHI 30
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic human insulin 30
McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
November 1998
November 1998   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
  • BMI (body mass index) below 39 kg/m^2
  • HbA1c (glycosylated haemoglobin) below 12%
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
 
NCT01697618
ANA/DCD/046
No
Not Provided
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