Insulin Glargine in Type 2 Diabetes Mellitus

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Subjects with Type 2 Diabetes mellitus for at least 1 year (no history of ketoacidosis) and treatment with oral antidiabetics (OAD) for at least 6 months prior to study entry. Body mass index \< or = 35 kg/m2.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: treatment with any insulin in the last 4 weeks prior to study entry; diabetes mellitus following pancreatectomy; GAD positive (glutamic acid decarboxylase).

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-06 with completion listed for 2005-05.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Change in fasting blood glucose, (FBG), Change in nocturnal blood glucose, Change in fasting plasma glucose, Change in mean daytime blood glucose, Change in mean daily blood glucose and Change in blood glucose at the remaining time points of the 8-point-blood glucose profiles.

What This Means in Plain Language

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

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

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