Insulin by Jet-injection for Hyperglycemia in Diabetes

What Was Tested

The trial (not phased) is built around Insulin Aspart.

It had two arms (groups): insujet is tested first (other) and insujet is tested second (other).

First procedure: experiment with the investigational product (Insujet pen)containing insulin aspart; second procedure: control device (conventional Novopen III insulin pen) contains insulin aspart.

First procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart.

The registry classes the interventions as drug.

More on the Plan

The faster insulin action of insulin administration by jet injection may be especially advantageous for correction of hyperglycemia.

To investigate this, a open-label randomised controlled cross-over study will be performed in 20 adult patients (18-75 years) with T1DM or T2DM on basal-bolus insulin treatment.

All patients will be investigated twice, where on one occasion the jet-injector device will be used to inject insulin, and on the other occasion insulin will be injected with a conventional insulin pen.

The order of these occasions will be randomised.

Who Took Part

20 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: Diabetes mellitus type 1 or 2. Age 18-75 years. Body-Mass Index ≥25 kg/m2 and ≤40 kg/m2. Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: inability to provide informed consent; treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs; known allergy to aspart insulin.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-03 with completion listed for 2014-11.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): T-BG≥10 (time frame: participants will be followed for the duration of the study, an expected average of 4 weeks).

It also tracked 9 secondary outcomes, for example T-BG5 and 8 (min), Rfall, BG-AUC 0-2h, BG-AUC 0-6h, C-INSmax (pmol/l) and T-INSmax.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 20 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.