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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: human soluble insulin; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02162407

NN304-1196

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

Insulin detemir 60 pmol/kg/min

Experimental group

Description:

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)

Treatment:

Drug: insulin detemir

Insulin detemir 120 pmol/kg/min

Experimental group

Description:

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)

Treatment:

Drug: insulin detemir

Human insulin 6 pmol/kg/min

Active Comparator group

Description:

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)

Treatment:

Drug: human soluble insulin