A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach blood sugar targets without low blood sugar episodes at night * The rate of low blood sugar episodes reported over a 24-hour period.

It had two arms (groups): LY2605541 (experimental) and Insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 466 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 type 2 diabetes mellitus for at least 1 year. Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2).

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: have used rosiglitazone, pramlintide, glucagon-like peptide 1 (glp-1) receptor agonist concurrently or within 90 days prior to screening; for participants on oams: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations; are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss.

How the Study Was Run

The set-up was randomized, parallel-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.

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 2012-05 with completion listed for 2013-05.

It ran at 61 sites in United States (33), Germany (5), Israel (5), Spain (5), Czechia (3) and Romania (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 weeks).

It also tracked 18 secondary outcomes, for example Change From Baseline to 52 Weeks in HbA1c, Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days), Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events, Fasting Serum Glucose (FSG) (by Laboratory), Fasting Blood Glucose (FBG) (by Self Monitoring) and Intra-participant Variability in Fasting Blood Glucose (FBG).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 466 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, all human trials.