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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin detemir
* Drug: human soluble insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin detemir 60 pmol/kg/min<br>Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) | Drug: insulin detemir<br>* Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp<br>|
| Experimental: Insulin detemir 120 pmol/kg/min<br>Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) | Drug: insulin detemir<br>* Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp<br>|
| Active Comparator: Human insulin 6 pmol/kg/min<br>Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) | Drug: human soluble insulin<br>* Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |