A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects

Novo Nordisk A/S0 sites37 target enrollmentAugust 2006

ConditionsDiabetes Healthy

Interventionsinsulin detemir

Drugsinsulin detemir

Overview

Phase: Phase 1
Intervention: insulin detemir
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 37
Primary Endpoint: AUC0-36h, area under the serum insulin detemir concentration curve
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

November 2006

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Non-smoker
•Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion Criteria

•Known or suspected allergy to trial products or related products
•Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
•A history of alcohol or drug abuse