Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.

It had two arms (groups): 1 (experimental) and 2 (experimental).

PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.

POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 345 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: Diagnosis of type 2 diabetes mellitus for at least six months. 18 to 70 years of age, inclusive. At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections per day) +/- metformin prior to study entry. Negative glutamic acid decarboxylase (GAD) autoantibodies. Ability and willingness to adhere to, and be compliant with, the study protocol.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: subjects treated with sulfonylureas, thiazolidinediones (tzds), or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin; planned pregnancy; or pregnant or lactating females; serum alt or ast levels greater than 2.5 x the upper limit of normal.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2004-08 with completion listed for 2007-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Compare change in weight from baseline to study week 52 in the per-protocol population of premeal Apidra vs postmeal Apidra, in patients receiving Lantus as basal insulin (time frame: 52 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 345 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.