A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Insulin Lispro.

Participants will be treated for up to 36 weeks with LY2605541 (one 12-week Lead-in period and two 12-week Randomization periods) and will participate in a total of 42 weeks of total study enrollment, including a 2-week Screening period and a 4-week Follow-up period.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This study involved a comparison of LY2605541 regimens, each administered with bolus insulin lispro.

Eligible participants were switched to a fixed evening LY2605541dosing regimen at the beginning of the 12-week lead-in period.

LY2605541 was administered SQ once-daily using a prefilled insulin device.

Each participant was crossed over to the alternate regimen after 12 weeks.

Who Took Part

Enrollment: 212 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: Type 1 diabetes mellitus for at least 1 year. Have a body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2). Currently using basal/ bolus insulin.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: have excessive insulin resistance; are taking medications other than insulin for diabetes; high triglycerides.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2013-02 with completion listed for 2014-04.

It ran at 18 sites in United States (17) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hemoglobin A1c (HbA1c) at 12 Weeks (time frame: At 12 Week in Each Randomization Period).

It also tracked 17 secondary outcomes, for example 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events, Percentage of Participants With Total and Nocturnal Hypoglycemic Events, Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose, Intra-Participant Variability of FBG at 12 Weeks, Fasting Serum Glucose (FSG) at 12 Weeks and Change From Randomization to 12 Weeks in 9-Point SMBG.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 212 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Lispro compound page, all human trials.