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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014