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 A/S
ClinicalTrials.gov Identifier:
NCT01487811
First received: December 5, 2011
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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
Diabetes
Healthy
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)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487811

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

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov 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:
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014