The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Detemir.

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

It had four arms (groups): A1, first period (experimental), A2, second period (active comparator), B1, first period (active comparator) and B2, second period (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 63 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin. Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months. Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs). Body mass index maximum 40.0 kg/m\^2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: use of glp-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (dpp-4) inhibitors within 3 months prior to screening; history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Detemir and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin Detemir, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2010-01 with completion listed for 2010-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir in 63 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, all human trials.