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Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01707160
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : January 4, 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 investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: biphasic insulin aspart 30 Drug: biphasic human insulin 30 Phase 1

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 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers
Study Start Date : November 1995
Actual Primary Completion Date : December 1995
Actual Study Completion Date : December 1995

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment period 1 Drug: biphasic insulin aspart 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Drug: biphasic human insulin 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Active Comparator: Treatment period 2 Drug: biphasic insulin aspart 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Drug: biphasic human insulin 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order




Primary Outcome Measures :
  1. Area under the Curve

Secondary Outcome Measures :
  1. Maximum insulin concentration (Cmax)
  2. Time to maximum insulin concentration (tmax)
  3. Minimum glucose concentration (Cmin(glu))
  4. Time to minimum glucose concentration (tmin(glu))
  5. Adverse events


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smokers
  • BMI (body mass index) maximum 27 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
  • FBG (fasting blood glucose) maximum 6.0 mmol/L

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): NCT01707160


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:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01707160     History of Changes
Other Study ID Numbers: ANA/DCD/031
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs