A Study in Participants With Type 1 Diabetes Mellitus

What Was Tested

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

The purpose of this study is: * To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment. * To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment. * To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.

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

LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

The registry classes the interventions as drug.

Who Took Part

455 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 had diabetes mellitus for at least 1 year. Have a body mass index (BMI) less than or equal to 35.0 kilograms per square meter (kg/m\^2). Have been treated for at least 90 days prior to screening with the following:. Insulin detemir, insulin glargine, or human insulin isophane suspension (NPH) insulin in combination with premeal insulin,. Self-mixed or premixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or.

The full record lists 14 inclusion and 21 exclusion criteria; among the exclusions: are using twice-daily insulin glargine having been inadequately controlled on once-daily dosed glargine prior to screening; lipid-lowering medications:; have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months.

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.

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 2012-01 with completion listed for 2013-05.

It ran at 51 sites in United States (12), Germany (9), France (8), Italy (6), Japan (4) and Poland (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c (HbA1c) at 26 Weeks (time frame: 26 weeks).

It also tracked 20 secondary outcomes, for example Hemoglobin A1c (HbA1c), Change From Baseline in Hemoglobin A1c (HbA1c), Total Hypoglycemia Rates (Adjusted by 30 Days), Percentage of Participants With Total Hypoglycemia Events, Nocturnal Hypoglycemia Rates (Adjusted by 30 Days) and Percentage of Participants With Nocturnal Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 455 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.