Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490099

Enrollment

Registered

2011-12-12

Start date

2006-08-31

Completion date

2006-11-30

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGinsulin detemir

One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
AUC0-36h, area under the serum insulin detemir concentration curve	From 0 to 36 hours
Cmax, maximum serum insulin detemir concentration	—

Secondary

Measure	Time frame
Terminal half life (t½)	—
AUC, area under the serum insulin detemir concentration curve	—
Adverse events	—
Area under the Curve Glucose Infusion Rate (AUCGIR)	—
Time to maximum concentration (tmax)	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026