Within-subject Variability of Insulin Detemir in Healthy Volunteers

A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497535

Enrollment

Registered

2011-12-22

Start date

2004-05-27

Completion date

2004-10-31

Last updated

2017-02-24

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 compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

Interventions

DRUGinsulin detemir

On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

DRUGinsulin glargine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Healthy Japanese men or women * Holding a Japanese pass-port and Japanese-born parents * Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body Mass Index (BMI) between 18 and 30 kg/m\^2, incl. * Fasting blood glucose maximum 6 mmol/L

Exclusion criteria

* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator * Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator * Subject with history of alcohol or drug dependence

Design outcomes

Primary

Measure	Time frame
Maximum glucose infusion rate (GIRmax)	—

Secondary

Measure	Time frame
Area under the glucose infusion rate curve (AUCGIR)	—
Time to maximum glucose infusion rate (tGIRmax)	—
Area under the insulin concentration curve (AUC)	—
Maximum insulin concentration (Cmax)	—
Adverse events	—

Countries

Germany

Outcome results

None listed

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