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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 5, 2011
Last updated: August 30, 2012
Last verified: August 2012
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 Intervention Phase
Drug: biphasic insulin aspart 30
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: May 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01487811

United States, Texas
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: William Lyness Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01487811     History of Changes
Other Study ID Numbers: BIASP-1669 
Study First Received: December 5, 2011
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Biphasic Insulins
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 04, 2016