Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

What Was Tested

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

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

It had two arms (groups): Insulin Lispro Mid Mixture (experimental) and Insulin Glargine (active comparator).

Insulin lispro mid mixture (MM) up to three times a day (TID).

Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

The registry classes the interventions as drug.

Who Took Part

484 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

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

Examples of who could join: Have type 2 diabetes.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: are taking any other glucose-lowering agents not mentioned in inclusion criterion; have a body mass index greater than 40 kg/m2; have had more than one episode of severe hypoglycemia in the last24 weeks.

How the Study Was Run

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

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 2006-08 with completion listed for 2008-09.

It ran at 25 sites in France (5), Spain (5), Canada (4), Australia (3), Russia (3) and South Korea (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hemoglobin A1c (HbA1c) at 36 Week Endpoint (time frame: 36 weeks).

It also tracked 11 secondary outcomes, for example Hemoglobin A1c (HbA1c) at Interval Visits, 7-point Self-monitored Blood Glucose Profiles, Glycemic Variability, Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia, 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) and Number of Patients With at Least One Severe Hypoglycemia Episode.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 484 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 Lispro compound page, all human trials.