Within-subject Variability of Insulin Detemir in Healthy Volunteers

NCT ID: NCT01497535

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-27
• Study Completion Date: 2004-10-31

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Insulin detemir

Group Type: EXPERIMENTAL

insulin detemir

Intervention Type: DRUG

On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

Insulin glargine

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

Interventions

insulin detemir

On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

Intervention Type: DRUG

insulin glargine

On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy Japanese men or women
• Holding a Japanese pass-port and Japanese-born parents
• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
• Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria

• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
• Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
• Subject with history of alcohol or drug dependence

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

NN304-1438

Identifier Type: -

Identifier Source: org_study_id