A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin

A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insulin Using Microperfusion Technique

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02162407

Enrollment

Registered

2014-06-12

Start date

1999-10-31

Completion date

1999-12-31

Last updated

2014-06-12

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 study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.

Interventions

DRUGinsulin detemir

Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

DRUGhuman soluble insulin

Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Healthy males between 19 and 50 years inclusive * The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject) * Body Mass Index (BMI) below 27 kg/m\^2 * Fasting blood glucose maximum 6 mmol/l

Exclusion criteria

* Participation in any other clinical trial involving other investigational products within the last 3 months

Design outcomes

Primary

Measure	Time frame
Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration	8 hours

Secondary

Measure	Time frame
Steady state glucose infusion rate (GIR)	8 hours
Steady state insulin interstitial concentration	8 hours
Ratio of steady state serum insulin concentration to interstitial insulin concentration	8 hours
Insulin concentration profiles	8 hours

Countries

Austria

Outcome results

None listed

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