Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal).

Insulin will also be given normally, subcutaneously, for control or comparison purposes.

The hypothesis or expectation is that ID insulin will work more quickly and control blood glucose levels better than SC injection.

It had five arms (groups): 1 (active comparator), 2 (active comparator), 3 (active comparator), 4 (active comparator) and 5 (experimental).

Regular insulin SC at -17 mins.

Regular insulin ID at -17 mins.

Regular insulin ID at -2 mins.

The registry classes the interventions as drug.

More on the Plan

Effects on the occurrence of hypoglycemia will also be investigated, as well as pK and pD comparisons between different insulin formulations administered ID.

This is a mono-center, open-label, randomized, 5-period crossover study in patients with type 1 diabetes.

Who Took Part

The registry lists 30 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Able to attend clinic for 5 different days.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: BMI \> 32 kg/m2; evidence of gastroparesis or impaired renal function or lipodystrophy.

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 Lispro and who got the comparison, which limits bias.

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

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

It started in 2007-09 with completion listed for 2007-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction (time frame: 90 mins).

It also tracked 7 secondary outcomes, for example Maximal BG (BGmax), Total BG-AUC0-4 h, Minimal BG (BGmin, time to BGmin (tBGmin), Number and seriousness of adverse events, Vital signs, examination of insulin application and Time to BGmax (tBGmax).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 30 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 Lispro compound page, all human trials.