Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- 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
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 Area under the serum insulin curve Maximum serum insulin concentration Terminal rate constant of insulin Adverse events Time to maximum glucose infusion rate. Time to maximum insulin concentration Terminal half-life of insulin
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Chula Vista, California, United States