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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01530048
First received: February 7, 2012
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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
Diabetes
Healthy
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC in the interval of 0-infinity hours [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • Terminal rate constant [ Designated as safety issue: No ]
  • Vz/f, volume of distribution during terminal phase [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • AUCGIR, area under the glucose infusion rate value curve [ Designated as safety issue: No ]
  • GIRmax, maximum glucose infusion rate value [ Designated as safety issue: No ]
  • tGIRmax, time to maximum glucose infusion rate value [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530048

Locations
Denmark
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mia S. Lundblad 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: NCT01530048     History of Changes
Other Study ID Numbers: PDS290-1750, 2005-005538-11
Study First Received: February 7, 2012
Last Updated: February 29, 2012
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on April 21, 2014