A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine.

Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.

It had 1 arm (groups): LY900014 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 187 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: Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening. Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:. Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals. Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening. Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:.

The full record lists 12 inclusion and 4 exclusion criteria; among the exclusions: have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults; have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening; have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-11-04 with completion listed for 2022-02-04.

It ran at 32 sites in United States (30) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12, Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12, Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12 and Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Insulin Glargine in 187 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.