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

What Was Tested

The trial (phase 3) is built around Insulin Aspart and Insulin Lispro.

Patients will continue to use their current insulin pump for this study.

Patients will receive insulin lispro and insulin aspart during this study.

One medication will be taken for 12 weeks and then the other medication for 12 weeks.

It had two arms (groups): Insulin Lispro 6 Day (6D) (experimental) and Insulin Aspart 6 Day (6D) (active comparator).

The registry classes the interventions as drug.

Who Took Part

133 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 (CSII) therapy for the previous 6 months. Baseline body mass index (BMI) less than or equal to 35.0 kilograms per meter squared (kg/m2).

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2010-11 with completion listed for 2011-12.

It ran at 15 sites in France (6), Germany (5) and Hungary (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use (time frame: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)).

It also tracked 4 secondary outcomes, for example Mean SMBG and Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Lispro in 133 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.