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Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01487811
First received: December 5, 2011
Last updated: August 30, 2012
Last verified: August 2012
History of Changes

December 5, 2011
August 30, 2012
May 2005
November 2005   (final data collection date for primary outcome measure)
  • Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity [ Designated as safety issue: No ]
  • Maximum drug concentration of the two formulations (Cmax) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01487811 on ClinicalTrials.gov Archive Site
  • Area under the concentration curve for insulin aspart from time 0 hours to 16 hours [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • Frequency of adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers
Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers

This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin)
  • Experimental: Formulation 1
    Intervention: Drug: biphasic insulin aspart 30
  • Active Comparator: Formulation 2
    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
50
November 2005
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI (body mass index) between 18 and 28 kg/m^2, both inclusive
  • Subject is a nonsmoker for at least 3 months
  • Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
  • Fasting plasma glucose between 80 and 110 mg/dl

Exclusion Criteria:

  • •Any clinically significant disease history of systemic or organ disease
  • •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
  • •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487811
BIASP-1669
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: William Lyness Novo Nordisk
Novo Nordisk
August 2012

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