Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

It had two arms (groups): 3 Day Algorithm (experimental) and Daily Algorithm (experimental).

Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the past three days. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B).

Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the previous day. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B).

The registry classes the interventions as drug.

More on the Plan

Both arms will add prandial insulin to existing basal insulin therapy.

Who Took Part

The registry lists 1117 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have type 2 diabetes. Have given written informed consent to participate in this study in accordance with local regulations.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: concomitant medications: glucagon-like peptide-1 (glp-1) receptor agonist, alpha-glucosidase inhibitor, or rosiglitazone use concurrently or within 3 months prior to entry into the study; morbid obesity: defined as a body mass index greater than or equal to 45 kilograms per square meter (kg/m²); hematologic: have known hemoglobinopathy or chronic anemia or other known blood disorder.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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 2010-12 with completion listed for 2013-01.

It ran at 76 sites in United States (33), Mexico (5), Puerto Rico (5), Poland (4), Argentina (3) and Brazil (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c) (time frame: Baseline, 24 weeks).

It also tracked 14 secondary outcomes, for example Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values, Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration, Change From Baseline to 24 Week Endpoint in Body Weight, Time to Reach Glycated Hemoglobin (HbA1c) Target Values, Change From Baseline to 24 Week Endpoint in Fasting Glucose and Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 1117 people.

With 1117 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.