Comparison of Two Formulations of Biphasic Insulin Aspart 70

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01523041
First received: January 25, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.


Condition Intervention Phase
Diabetes
Healthy
Drug: biphasic insulin aspart 70
Drug: biphasic insulin aspart 50
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the insulin aspart curve in the interval from 0-24 hours [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]
  • tmax, the time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Cmin, minimum glucose concentration [ Designated as safety issue: No ]
  • tmin, time to minimum concentration [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 1999
Study Completion Date: November 1999
Primary Completion Date: November 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 70 clinical trial formulation Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin)
Experimental: BIAsp 70 final formulation Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin)
Experimental: BIAsp 50 final formulation Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin)

Detailed Description:

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caucasian
  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body mass index (BMI) between 19-27 kg/m^2
  • Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion Criteria:

  • Participation in any other clinical trial involving other investigational products within the last three months
  • Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
  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: NCT01523041

Locations
United Kingdom
Leeds, United Kingdom, LS2 9NG
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Benedikte Lertoft 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: NCT01523041     History of Changes
Other Study ID Numbers: BIASP-1144
Study First Received: January 25, 2012
Last Updated: January 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Biphasic Insulins
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014