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Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT01527552
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: biphasic insulin aspart 50 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Actual Study Start Date : November 5, 2002
Actual Primary Completion Date : December 18, 2002
Actual Study Completion Date : December 18, 2002

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Formulation A Drug: biphasic insulin aspart 50
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
Experimental: Formulation B Drug: biphasic insulin aspart 50
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days


Outcome Measures
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Primary Outcome Measures :
  1. Area under the insulin aspart curve in the interval from 0-16 hours
  2. Cmax, maximum insulin aspart concentration

Secondary Outcome Measures :
  1. tmax, the time to maximum insulin aspart concentration
  2. Area under the insulin aspart curve
  3. Mean residence time (MRT)
  4. The area under the glucose infusion rate curve
  5. GIRmax, maximum glucose infusion rate value
  6. tGIRmax, time to maximum glucose infusion rate value
  7. Adverse events

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
  • Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
  • Minimum body weight of 65 kg
  • Fasting blood glucose between 3.8-6.0 mmol/L
  • Glycohemoglobin (HbA1c) below 6.4 %
  • Non-smokers

Exclusion Criteria:

  • Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
  • History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
  • Hepatitis B or C
  • Subjects with a first-degree relative with diabetes mellitus
  • Known or suspected allergy to trial product or related products
  • Smoking during the past three months
Contacts and Locations
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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): NCT01527552


Locations
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South Africa
Novo Nordisk Investigational Site
Bloemfontein, South Africa, 9324
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01527552    
Other Study ID Numbers: BIASP-1488
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
 Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs