A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

What Was Tested

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

It had three arms (groups): one (experimental), one (experimental) and Insulin Glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason.

The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason.

For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.

Who Took Part

884 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 2 diabetes. Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications. Willing to inject subcutaneous medication. Willing to maintain a study diary. Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2).

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetes; previous therapy with glucagon-like peptide 1 (glp-1) agonists within 3 months prior to screening; 1 or more episodes of ketoacidosis within 6 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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 2010-11 with completion listed for 2012-02.

It ran at 101 sites in United States (36), Hungary (7), Spain (6), Canada (5), Denmark (5) and Taiwan (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 26 weeks).

It also tracked 29 secondary outcomes, for example Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c), Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles, Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose, Change From Baseline to 26 and 52 Weeks in Body Weight, Change From Baseline to 26 and 52 Weeks in the EQ-5D and Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 884 people.

With 884 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.