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

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ClinicalTrials.gov Identifier: NCT01487811
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: biphasic insulin aspart 30 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Formulation 1 Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin)
Active Comparator: Formulation 2 Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin)


Outcome Measures
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Primary Outcome Measures :
  1. Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
  2. Maximum drug concentration of the two formulations (Cmax)

Secondary Outcome Measures :
  1. Area under the concentration curve for insulin aspart from time 0 hours to 16 hours
  2. Mean residence time (MRT)
  3. Frequency of adverse events

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487811


Locations
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United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487811    
Other Study ID Numbers: BIASP-1669
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Insulin Aspart
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs