A Randomised, Single Centre, Double-blind, Two-period Crossover, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin 454 Formulations, With or Without Buffer, and Between Two SIAC Formulations, With or Without Buffer, in Healthy Male Subjects

Novo Nordisk A/S0 sites58 target enrollmentMay 2008

ConditionsDiabetes Healthy

Interventionsinsulin degludec insulin degludec/insulin aspart

Drugsinsulin degludec insulin degludec/insulin aspart

Overview

Phase: Phase 1
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 58
Primary Endpoint: Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

August 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject
•Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
•Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (inclusive)
•Fasting plasma glucose below or equal to 6 mmol/L
•Sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. This serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication

Exclusion Criteria

•A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
•Known or suspected allergy to trial products or related products
•Subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing