Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin detemir; Drug: insulin NPH

• Registration Number: NCT01497600
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
insulin detemir	insulin NPH	-
insulin NPH	insulin NPH	-
insulin detemir	insulin detemir	-
insulin NPH	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve

Secondary Outcome Measures

Name	Time	Method
Maximum glucose infusion rate
Terminal rate constant of insulin
Adverse events
Time to maximum glucose infusion rate.
Terminal half-life of insulin
Area under the serum insulin curve
Maximum serum insulin concentration
Time to maximum insulin concentration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Chula Vista, California, United States