Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

This study is an open label, prospective, randomised comparative, single center study.

In the present study, the impact of a 12-week pulsatile insulin infusion therapy (PIT) with Humulin R 100 from.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

During the screening visit the patient will arrive at the study site and written informed consent will be obtained.

Inclusion and exclusion criteria will be controlled and blood will be drawn for HbA1c and safety parameters.

Patient demographics and history will be collected and a physical examination will be performed.

Also, the randomization (2 h vs 3 h) will be performed.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Informed consent obtained prior to any trial-related activities. Male or female \> 18 years.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: patients participating in another investigational drug study; current or history of dialysis therapy; patients with diagnosed renal failure from non-diabetic etiology.

How the Study Was Run

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

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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

It started in 2019-09-06 with completion listed for 2020-10-19.

It ran at 2 sites in United States (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Endothelial function (time frame: 1 hour).

It also tracked 6 secondary outcomes, for example Renal function, nerve function, Retinopathy, HbA1c and Insulin resistance.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 24 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 (regular human) compound page, all human trials.