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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530048
• Other study ID #: PDS290-1750
• Secondary ID: 2005-005538-11
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2012
• Last updated: October 14, 2016
• Start date: March 2006
• Est. completion date: May 2006

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) in the interval of 0-6 hours			No
Primary	Cmax, maximum concentration			No
Secondary	AUC in the interval of 0-infinity hours			No
Secondary	tmax, time to reach Cmax			No
Secondary	Terminal rate constant			No
Secondary	Vz/f, volume of distribution during terminal phase			No
Secondary	t½, terminal half-life			No
Secondary	AUCGIR, area under the glucose infusion rate value curve			No
Secondary	GIRmax, maximum glucose infusion rate value			No
Secondary	tGIRmax, time to maximum glucose infusion rate value			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk