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Comparison of Two Formulations of Biphasic Insulin Aspart 70

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ClinicalTrials.gov Identifier: NCT01523041
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Healthy Drug: biphasic insulin aspart 70 Drug: biphasic insulin aspart 50 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Actual Study Start Date : November 3, 1999
Actual Primary Completion Date : November 30, 1999
Actual Study Completion Date : November 30, 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Area under the insulin aspart curve in the interval from 0-24 hours

Secondary Outcome Measures :
  1. Cmax, maximum insulin aspart concentration
  2. tmax, the time to maximum insulin aspart concentration
  3. t½, terminal half-life
  4. Cmin, minimum glucose concentration
  5. tmin, time to minimum concentration


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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

Information from the National Library of Medicine

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): 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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01523041     History of Changes
Other Study ID Numbers: BIASP-1144
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 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