A Study in Participants With Type I Diabetes Mellitus

What Was Tested

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

The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 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 52 weeks of treatment. * To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 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 subcutaneously (SC) once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered SC at meal times for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

1114 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 for at least 1 year. HbA1c value less than 12 percent according to the central laboratory at screening. Body mass index of 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. Insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH) in combination with pre-meal insulin, or.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: lipid lowering medications:; are using niacin preparations as lipid lowering medication and/or bile acid sequestrants within 90 days prior to screening; or,; have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2012-01 with completion listed for 2014-02.

It ran at 119 sites in United States (47), United Kingdom (11), Canada (7), Poland (7), Spain (7) and Israel (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c (HbA1c) (time frame: 52 weeks).

It also tracked 21 secondary outcomes, for example Hemoglobin A1c (HbA1c), Change From Baseline to 52 Weeks in HbA1c, Total Hypoglycemia Events, Percentage of Participants With Total Hypoglycemic Events, Nocturnal Hypoglycemia Rates 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 1114 people.

With 1114 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.