The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes

What Was Tested

The trial (phase 3) is built around Amylin (Islet Amyloid Polypeptide).

The registry classes the interventions as drug.

More on the Plan

In healthy individuals, an "after meal" blood sugar level is very carefully controlled.

Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in maintaining this careful balance.

In T1DM, there is a lack of insulin and failure of glucagon suppression (keeping glucagon from being made too much).

This leads to hyperglycemia (high blood sugar) right after you eat food.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 12 years up to 21 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Between 12-21 years of age at the time of enrollment. Be on continuous subcutaneous insulin infusion using an insulin pump. Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism. Menstruating women must have a negative pregnancy test. Weight more than 44 kg. -.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: age greater than 22 years or less than 12 years at the time of study; lack of a supportive family environment; positive pregnancy test in menstruating young women.

How the Study Was Run

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

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

Everyone knew when Amylin (Islet Amyloid Polypeptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2003-10 with completion listed for 2006-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the curve for glucose.

It also tracked 1 secondary outcome, for example glucagon and gastric emptying.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amylin (Islet Amyloid Polypeptide) in 20 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 Amylin (Islet Amyloid Polypeptide) compound page, all human trials.