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
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: 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
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014