Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart and Insulin Lispro.

This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study.

The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion \[CSII\]) compared to insulin aspart over 6 days of pump reservoir in-use.

The study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.

It had three arms (groups): Insulin Lispro 2 Day (active comparator), Insulin Lispro 6 Day (experimental) and Insulin Aspart 6 Day (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 132 actual participants took part.

It was open to people of any sex aged from 13 years with no upper age limit.

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

Examples of who could join: Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months. Treated with continuous subcutaneous insulin infusion therapy for the previous 6 months. Baseline body mass index (BMI) less than or equal to 35.0 kg/m\^2.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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

It started in 2010-04 with completion listed for 2011-08.

It ran at 11 sites in United States (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use (time frame: 8 weeks of each treatment).

It also tracked 12 secondary outcomes, for example Mean SMBG, Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values, Percentage of Participants With Hyperglycemia, Hyperglycemic Episode Rate Per 30 Days, Percentage of Participants With Pump Complications and Pump Complication Rate Per 30 Days.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Lispro in 132 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Lispro compound page, all human trials.