Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

All subjects will be on BID NPH intermediate acting insulin therapy.

If subject is using long acting insulin (Glargine, Detemir, etc.), he/she must be switched to NPH intermediate acting insulin.

If on insulin analogue (Novolog, Lispro, Aspart, Aphidra, Glulisine, or any other analogue available in the subject's geographical area), the subject must be switched to regular human insulin 3 times a day.

Who Took Part

The registry lists 500 planned participants were the target.

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: Be male or female between the ages 18 to 75 years. Have a body mass index (BMI) \<27;. Willing to give written informed consent prior to admission into the study.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);; have hypoglycemia unawareness;; have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2008-04 with completion listed for 2011-08.

It ran at 74 sites in Russia (27), Poland (9), Romania (9), United States (8), Ukraine (8) and Bulgaria (6).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 500 people.

With 500 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.