Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With Non-insulin-dependent Diabetes Mellitus (NIDDM)

What Was Tested

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

The aim of the study is to determine whether meal induced platelet activation is related to post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with rapidly acting insulin in patients with T2DM.

The registry classes the interventions as drug.

More on the Plan

Each patient is admitted in the fasting state, on 3 different occasions .

The order of injections in the cross over study is randomized and blinded to the patient and to the investigators.

The patient eats the meal and is followed up for 90 minutes after completion of the meal.

Blood tests for platelet function and other parameters are taken at 3 main points: 1. before glucose normalization. 2\. 15 minutes after glucose normalization, and right before the meal. 3. 90 minutes after the meal.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged up to 70 years.

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

Examples of who could join: Type II Diabetes Mellitus. Antecubital forearm veins allowing technically good sampling for platelet studies. Below 70 years.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of a cardiovascular disease; ischemic heart disease, stroke, peripheral vascular disease; acute or chronic renal or liver disease; contraindication to insulin treatment.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

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 and investigator.

It started in 2007-05 with completion listed for 2011-07.

It ran at 1 site in Sweden.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): To evaluate if platelet activation following a carbohydrate rich meal is related to the post-prandial hyperglycemia, and thus can be attenuated by premeal insulin treatment in patients with T2DM (time frame: 90 minutes after the meal). Co- primary platelet response variables: U46619 stimulated platelet P- selectin activation, platelet-leukocyte aggregation, platelet-platelet aggregates and platelet-monocyte aggregates (time frame: After completion of the study in 20 patients).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 18 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.