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Trial record 10 of 545 for:    INSULIN ASPART

A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02089451
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: Faster-acting insulin aspart Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects
Actual Study Start Date : March 17, 2014
Actual Primary Completion Date : June 6, 2014
Actual Study Completion Date : June 6, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FIAsp
Each subject will be randomised to a treatment sequence consisting of 5 treatment periods
Drug: Faster-acting insulin aspart
Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)




Primary Outcome Measures :
  1. Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration) [ Time Frame: From 0 to 12 hours ]

Secondary Outcome Measures :
  1. Area under the serum insulin aspart concentration-time curve (only for intramuscular administration) [ Time Frame: From 0 to 12 hours ]
  2. Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration) [ Time Frame: From 0 to 12 hours ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 18-64 years both inclusive at the time of signing informed consent
  • Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
  • Body mass index 20.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

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): NCT02089451


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02089451     History of Changes
Other Study ID Numbers: NN1218-3949
2011-002590-32 ( EudraCT Number )
U1111-1121-8351 ( Other Identifier: WHO )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: February 17, 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
Hypoglycemic Agents
Physiological Effects of Drugs