Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

What Was Tested

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

This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.

It had two arms (groups): Insulin Lispro, then Insulin Aspart (active comparator) and Insulin Aspart, then Insulin Lispro (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study will provide clinical information on the use of insulin lispro in continuous subcutaneous insulin infusion (CSII) in participants with type 2 diabetes.

The study design includes the following periods: Screening/Randomization, Treatment Period 1 (16 weeks), and Treatment Period 2 (16 weeks).

Who Took Part

122 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 (per World Health Organization \[WHO\] Classification of Diabetes). Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months. Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening.

The full record lists 6 inclusion and 5 exclusion criteria.

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.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

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, investigator and outcomes assessor.

It started in 2011-12 with completion listed for 2013-02.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycosylated Hemoglobin A1C (HbA1c) at Endpoint (time frame: After 16 weeks of each treatment (Periods1 and 2)).

It also tracked 4 secondary outcomes, for example Rate of Hypoglycemic Events Per 30 Days, Change From Baseline in Weight and Percentage of Participants With Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Lispro in 122 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.