A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart

Novo Nordisk A/S1 site in 1 country35 target enrollmentApril 1999

ConditionsDiabetes Healthy

Interventionsbiphasic insulin aspart 30 biphasic insulin aspart 50 biphasic insulin aspart 70 insulin aspart

Drugsbiphasic insulin aspart 30 biphasic insulin aspart 50 biphasic insulin aspart 70 insulin aspart

Overview

Phase: Phase 1
Intervention: biphasic insulin aspart 30
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 35
Locations: 1
Primary Endpoint: Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Registry

clinicaltrials.gov

Start Date

April 1999

End Date

May 2000

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index between 18 and 28 kg/m\^2 inclusive
•HbA1c within the normal laboratory range
•Non smoker for at least three months
•Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria

•Subjects who have received any investigational drug in the 3 months prior to the start of dosing
•Any disease requiring regular use of non topical prescription medicines
•Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
•Any intercurrent illness or endocrine disorders that may affect blood glucose
•Subject with a history of drug or alcohol dependence
•Subject with a first degree relative with diabetes mellitus
•Subject with a history of clinically relevant allergic reactions to medical products
•Subjects who have donated any blood or plasma in the past 3 month preceding screening