Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 4 trial tested Insulin Aspart and Insulin Lispro.

It had three arms (groups): sequence 1 (experimental), Sequence 2 (experimental) and Sequence 3 (experimental).

Sequence 1: insulin glulisine / insulin aspart / insulin lispro.

Sequence 2: insulin aspart / insulin lispro / insulin glulisine.

Sequence 3: insulin lispro / insulin glulisine / insulin aspart.

The registry classes the interventions as drug.

Who Took Part

289 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 1 diabetic subjects. Treated with insulin for at least 2 years and by CSII for at least 6 months. Using the same type of infusion set (catheter and cannula) for at least 3 months. Performing at least 3 blood glucose controls per day. Body mass index (BMI) \< 35 kg/m².

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: diabetes other than type 1; using an insulin pump requiring pre-filled cartridges; history of infection at infusion site requiring a drainage in the last 3 months.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2008-01 with completion listed for 2009-06.

It ran at 12 sites in United States (1), Australia (1), Austria (1), France (1), Hungary (1) and Israel (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion (time frame: over 13 weeks of each treatment period).

It also tracked 16 secondary outcomes, for example Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion, Percentage of Patients With at Least One Unexplained Hyperglycemia, Monthly Rate of Unexplained Hyperglycemia, Percentage of Patients With at Least One Confirmed Infusion Set Occlusion, Monthly Rate of Confirmed Infusion Set Occlusion and Rate of Severe Symptomatic Hypoglycemia Per Patient-year.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Lispro in 289 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.