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

Novo Nordisk A/S13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Healthy

Interventions

insulin detemirDRUG

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

human soluble insulinDRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Graz, Austria

Outcomes

Primary Outcomes

Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration

Time frame: 8 hours

Secondary Outcomes

Steady state glucose infusion rate (GIR)

Time frame: 8 hours

Steady state insulin interstitial concentration

Time frame: 8 hours

Ratio of steady state serum insulin concentration to interstitial insulin concentration

Time frame: 8 hours

Insulin concentration profiles

Time frame: 8 hours

Data from ClinicalTrials.gov

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