Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)

• Duration of diabetes at least 12 months

• Body Mass Index (BMI) below 33 kg/m^2

• HbA1c maximum 10 % based on analysis from the central laboratory

Exclusion Criteria:

• Current treatment with insulin above 1.2 U/kg/day

• Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors

• Blood donation of more than 500 mL within the last three months