Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Origin and Whites Not of Hispanic or Latino Origin With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin detemir<br> | Drug: insulin detemir<br>* Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)<br>Drug: insulin NPH<br>* Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)<br>|
| Active Comparator: insulin NPH<br> | Drug: insulin detemir<br>* Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)<br>Drug: insulin NPH<br>* Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose infusion rate |  |  | 
| Time to maximum glucose infusion rate. |  |  | 
| Area under the serum insulin curve |  |  | 
| Maximum serum insulin concentration |  |  | 
| Time to maximum insulin concentration |  |  | 
| Terminal rate constant of insulin |  |  | 
| Terminal half-life of insulin |  |  | 
| Adverse events |  |  |