A Study in Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Lispro.

The purpose of this study is: * To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. * To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. * To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

It had two arms (groups): Insulin Glargine + Insulin Lispro (active comparator) and LY2605541 + Insulin Lispro (experimental).

The registry classes the interventions as drug.

Who Took Part

1369 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification. Had diabetes ≥1 year. Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2). Participants on any glucose lowering regimen that contains at least 1 daily insulin injection. This inclusion criterion applies ONLY to women of childbearing potential.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-12 with completion listed for 2013-08.

It ran at 156 sites in United States (48), Germany (9), Australia (7), Croatia (6), Israel (6) and Czechia (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks (time frame: Baseline, 26 weeks).

It also tracked 19 secondary outcomes, for example Total Hypoglycemia Rates (Adjusted for 30 Days), Percentage of Participants With Total Hypoglycemia Episodes, Nocturnal Hypoglycemia Rates (Adjusted for 30 Days), Percentage of Participants With Nocturnal Hypoglycemia Episodes, Body Weight Change From Baseline to 26 Weeks and Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 1369 people.

With 1369 participants it is a large trial for this field.

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.