Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.

The registry classes the interventions as drug.

Who Took Part

281 planned participants were the target.

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. Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study. Negative glutamic acid decarboxylase (GAD) autoantibodies. Ability and willingness to adhere to, and be compliant with, the study protocol. Must be able to read English at the sixth grade level in order to complete the patient-reported outcomes component of the study.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: planned pregnancy; or pregnant or lactating females; serum alt or ast levels greater than 2.5 x the upper limit of normal; any current malignancy or any cancer within the past 5 years (except for adequately treated basal cell skin cancer or cervical carcinoma in situ).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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 2004-04 with completion listed for 2005-08.

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 3, randomized trial of Insulin Glargine in 281 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.