Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals).

The registry classes the interventions as drug.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Must have type 2 diabetes. Must be 30-75 years of age at the time of Visit 1. Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: must not have used rapid/short-acting insulin on a regular basis in the last 6 months; must not have more than one episode of severe hypoglycemia in the last 6 months; must not have a body mass index (bmi) of greater than 45 (morbid obesity).

How the Study Was Run

Design: randomized, single-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.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-04 with completion listed for 2006-04.

It ran at 48 sites in United States (44) and Puerto Rico (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination. with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal.

It also tracked 3 secondary outcomes, for example To test in both arms the following: frequency and incidence and body weight, SAE's and study drug related AEs.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 300 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 and the Insulin Lispro compound page, all human trials.