Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497600

Enrollment

Registered

2011-12-22

Start date

2004-02-29

Completion date

2004-08-31

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin detemir

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)

DRUGinsulin NPH

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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion rate curve	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026