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Completed

NCT Number: NCT02162407

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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

human soluble insulin

Drug

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

Primary outcomes

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

    Time frame: 8 hours

Secondary outcomes

  1. Steady state glucose infusion rate (GIR)

    Time frame: 8 hours

  2. Steady state insulin interstitial concentration

    Time frame: 8 hours

  3. Ratio of steady state serum insulin concentration to interstitial insulin concentration

    Time frame: 8 hours

  4. Insulin concentration profiles

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
1999
Study completion
1999
First posted
Jun 12, 2014
Registry last updated
Jun 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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