Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: February 7, 2012
Last updated: October 14, 2016
Last verified: October 2016
This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Condition Intervention Phase
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Area under the curve (AUC) in the interval of 0-6 hours
  • Cmax, maximum concentration

Secondary Outcome Measures:
  • AUC in the interval of 0-infinity hours
  • tmax, time to reach Cmax
  • Terminal rate constant
  • Vz/f, volume of distribution during terminal phase
  • t½, terminal half-life
  • AUCGIR, area under the glucose infusion rate value curve
  • GIRmax, maximum glucose infusion rate value
  • tGIRmax, time to maximum glucose infusion rate value
  • Adverse events

Enrollment: 34
Study Start Date: March 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: U200 Drug: insulin aspart
A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between
Active Comparator: U100 Drug: insulin aspart
A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between


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

Inclusion Criteria:

  • Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
  • Body mass index between 18 and 27 kg/m^2 (both inclusive)
  • Non-smoker
  • Fasting blood glucose maximum 6 mmol/L
  • HbA1c below 6.4%

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
  • Clinically significant abnormal laboratory values (as judged by the Investigator)
  • Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
  • Intake of alcohol within the last 24 hours prior to screening and drug administration visits
  • Blood donation or blood loss of more than 500 mL within the 3 last months before screening
  • Strenuous exercise within 48 hours before screening as well as drug administration and followup
  • Smoking during the past month before drug administration
  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 identifier: NCT01530048

Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01530048     History of Changes
Other Study ID Numbers: PDS290-1750
2005-005538-11 ( EudraCT Number )
Study First Received: February 7, 2012
Last Updated: October 14, 2016

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 23, 2017