Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Detemir and NPH Insulin (isophane).

This trial is conducted in the United States of America (USA).

It had two arms (groups): insulin detemir (experimental) and insulin NPH (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.

Each person switched between Insulin Detemir and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Detemir.

Those kept unaware of assignments: participant and investigator.

It started in 2004-02 with completion listed for 2004-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the glucose infusion rate curve.

It also tracked 8 secondary outcomes, for example 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 and Terminal rate constant of insulin.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.