Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Detemir.

This trial is conducted in Asia, South America and the United States of America (USA).

It had two arms (groups): IDet (experimental) and IGlar (active comparator).

The registry classes the interventions as drug.

Who Took Part

457 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: Diagnosed with type 2 diabetes for at least 6 months. Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed). Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: any contraindication to insulin detemir or insulin glargine according to the local labelling; receipt of any investigational product within 4 weeks; any other condition that the investigator feels would interfere with trial participation or evaluation of results.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2009-05 with completion listed for 2010-06.

It ran at 88 sites in United States (71), Argentina (4), South Korea (4), Thailand (4), India (3) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Baseline (time frame: Week 0, Week 26).

It also tracked 13 secondary outcomes, for example Fasting Plasma Glucose (FPG), Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast, Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles), Incidence of Hypoglycaemic Episodes During the Trial, Hypoglycaemic Episodes, Diurnal and Hypoglycaemic Episodes, Nocturnal.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 457 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Detemir compound page, all human trials.