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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin detemir; Drug: human soluble insulin

• Registration Number: NCT02162407
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-10
• Primary Completion: 1999-12
• Study Completion: 1999-12
• Study First Submitted: 2014-05-22
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-10
• Last Update Submitted: 2014-06-10
• Study First Posted: 2014-06-12
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin detemir 60 pmol/kg/min	insulin detemir	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)
Insulin detemir 120 pmol/kg/min	insulin detemir	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)
Human insulin 6 pmol/kg/min	human soluble insulin	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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