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

NCT ID: NCT02162407

Last Updated: 2014-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

1999-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insulin detemir 60 pmol/kg/min

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)

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

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

Insulin detemir 120 pmol/kg/min

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)

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

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

Human insulin 6 pmol/kg/min

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)

Group Type ACTIVE_COMPARATOR

human soluble insulin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin detemir

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

Intervention Type DRUG

human soluble insulin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NN304-1196

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Basal Insulins - Pharmacodynamics
NCT00566124 COMPLETED PHASE4
Hospital In-Patient Insulin Study
NCT00135070 TERMINATED PHASE4