The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients

What Was Tested

In this phase 2 trial, researchers set out to test Pancreatic Polypeptide.

It had two arms (groups): Saline Placebo (placebo comparator) and Pancreatic Polypeptide (active comparator).

Saline.

Pancreatic Polypeptide.

The registry classes the interventions as drug.

More on the Plan

The pancreas is a large gland located behind the stomach.

One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide.

Insulin helps the cells to take in glucose.

However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well.

Who Took Part

8 actual participants took part.

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: Male and female volunteers between the ages of 18-75 with:. HbA1c levels ≤ 8.5.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: lactating or pregnant females; brittle or labile diabetics: volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason; allergy to beef or beef by-products.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Pancreatic Polypeptide and who got the comparison, which limits bias.

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

In this single-blind Pancreatic Polypeptide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2007-10 with completion listed for 2010-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total Amount of Insulin Administered While on Placebo/PP (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pancreatic Polypeptide in 8 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Pancreatic Polypeptide compound page, all human trials.