A Study in Adults With Type 1 Diabetes

What Was Tested

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

It had two arms (groups): LY2963016 + Insulin Lispro (experimental) and Lantus + Insulin Lispro (active comparator).

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 536 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 1 diabetes mellitus based on the disease diagnostic criteria \[World Health Organization (WHO) Classification\]. Have duration of diabetes greater than or equal to one year. Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins; have active cancer or cancer within the past 5 years.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

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

It started in 2011-08 with completion listed for 2012-08.

It ran at 52 sites in United States (21), Japan (6), Romania (5), Germany (4), Mexico (4) and Belgium (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, Endpoint (up to 24 weeks)).

It also tracked 12 secondary outcomes, for example Change From Baseline in Insulin Antibody Levels, Change From Baseline in Hemoglobin A1c (HbA1c), 7-Point Self-Monitored Blood Glucose (SMBG) Profiles, Glycemic Variability of Fasting Blood Glucose, Change From Baseline in Body Weight and Adult Low Blood Sugar Survey (ALBSS).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 536 people.

With 536 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.