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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162407
• Other study ID #: NN304-1196
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2014
• Last updated: June 10, 2014
• Start date: October 1999
• Est. completion date: December 1999

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 1999
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin detemir
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp
• human soluble insulin
Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration		8 hours	No
Secondary	Steady state glucose infusion rate (GIR)		8 hours	No
Secondary	Steady state insulin interstitial concentration		8 hours	No
Secondary	Ratio of steady state serum insulin concentration to interstitial insulin concentration		8 hours	No
Secondary	Insulin concentration profiles		8 hours	No

External Links

•   Clinical Trials at Novo Nordisk