Within-subject Variability of Insulin Detemir in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497535
• Other study ID #: NN304-1438
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2011
• Last updated: February 22, 2017
• Start date: May 27, 2004
• Est. completion date: October 31, 2004

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2004
• Est. primary completion date: October 31, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum glucose infusion rate (GIRmax)
Secondary	Area under the glucose infusion rate curve (AUCGIR)
Secondary	Time to maximum glucose infusion rate (tGIRmax)
Secondary	Area under the insulin concentration curve (AUC)
Secondary	Maximum insulin concentration (Cmax)
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk