Oral Insulin: A Comparison With Subcutaneous Regular Human Insulin in Patients With Type 2 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Oral Insulin (experimental) and Subcutaneous Insulin (active comparator).

Oral insulin capsule formulation.

Subcutaneous injection of regular human insulin.

The registry classes the interventions as drug.

More on the Plan

This study was a single centre, randomized, 3-period crossover study performed in patients with type 2 diabetes.

Who Took Part

The registry lists 10 actual participants took part.

It was open to men only aged from 35 years up to 70 years.

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

Examples of who could join: Male subjects between the ages of 35 and 70 years, inclusive, with Type 2 diabetes mellitus as defined by the ADA criteria for more than one year. Subjects must have Body Mass Index (BMI) \< 36 kg/m². Subjects must refrain from strenuous physical activity beginning 72 hours prior to admission and through the duration of the study. Subjects must be willing and able to be confined to the Clinical Research Unit as required by the protocol. Subjects must be willing and able to provide written informed consent.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: subjects with gastroparesis, orthostatic hypotension and hypoglycemia unawareness (autonomic neuropathy); positive hepatitis b (hepatitis b surface antigen) and/or hepatitis c (hepatitis c antibody) serology; positive hiv serology.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2001-10 with completion listed for 2001-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glucose Infusion Rate (GIR).

It also tracked 3 secondary outcomes, for example Plasma insulin concentration, Plasma C-Peptide and Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 10 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.