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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01697618
First received: September 28, 2012
Last updated: October 2, 2012
Last verified: September 2012

September 28, 2012
October 2, 2012
April 1997
November 1998   (final data collection date for primary outcome measure)
Area under the serum insulin curve [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
  • Cmax (maximum plasma concentration) [ Designated as safety issue: No ]
  • tmax (time to reach maximum) [ Designated as safety issue: No ]
  • Area under the curve following each injections derived from 24 hours serum insulin profiles [ Designated as safety issue: No ]
  • Overall shape of the 24 hour serum glucose profile [ Designated as safety issue: No ]
  • Serum glucose excursions (EXC) [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   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%
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT01697618
ANA/DCD/046
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Lisbeth V. Jacobsen Novo Nordisk A/S
Novo Nordisk A/S
September 2012

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