Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01707160
First received: October 10, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Diabetes
Healthy
Drug: biphasic insulin aspart 30
Drug: biphasic human insulin 30
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Curve [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum insulin concentration (Cmax) [ Designated as safety issue: No ]
  • Time to maximum insulin concentration (tmax) [ Designated as safety issue: No ]
  • Minimum glucose concentration (Cmin(glu)) [ Designated as safety issue: No ]
  • Time to minimum glucose concentration (tmin(glu)) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 1995
Study Completion Date: December 1995
Primary Completion Date: December 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707160

Locations
United Kingdom
Leeds, United Kingdom, LS2 9NG
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lisbeth V. Jakobsen, M.sc. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01707160     History of Changes
Other Study ID Numbers: ANA/DCD/031
Study First Received: October 10, 2012
Last Updated: October 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014