Pharmacokinetics of IAsp Following CSII in Patients With T1DM

What Was Tested

The trial (phase 4) is built around Insulin Aspart.

The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.

The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (active comparator).

≈ bolus protocol.

≈ CSII protocol.

≈ CIII protocol.

The registry classes the interventions as drug.

More on the Plan

Rapid acting insulin, like insulin aspart, can be administered as CSII.

The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.

Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency.

The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Type 1 diabetes mellitus (T1DM). 18 years \< age \< 50 years. Time since diagnosis of T1DM ≥ 5 years. Being able to understand and read Danish.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: dysregulation of endocrine disorders other than type 1 diabetes mellitus; severe dysregulation of diabetes mellitus; other severe adverse disease.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2007-07 with completion listed for 2008-07.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: CV SSPIasp (time frame: 6 hours).

It also tracked 1 secondary outcome, for example • Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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