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Comparison of Two Formulations of Biphasic Insulin Aspart 70

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01523041
First received: January 25, 2012
Last updated: February 22, 2017
Last verified: February 2017
  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
Intervention Model: Crossover Assignment
Masking: Participant, 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

Secondary Outcome Measures:
  • Cmax, maximum insulin aspart concentration
  • tmax, the time to maximum insulin aspart concentration
  • t½, terminal half-life
  • Cmin, minimum glucose concentration
  • tmin, time to minimum concentration

Enrollment: 24
Actual Study Start Date: November 3, 1999
Study Completion Date: November 30, 1999
Primary Completion Date: November 30, 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   (Adult)
Sexes 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
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS2 9NG
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: 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: February 22, 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2017