A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Amylin (Islet Amyloid Polypeptide).

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 12 years up to 17 years.

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

Examples of who could join: Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening. Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening. Body weight \>=50 kg at screening.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: currently being treated with the following medications: \*any oral antihyperglycemic agent; \*drugs that directly affect gastrointestinal motility; has been previously treated with symlin/pramlintide (or has participated in a symlin/pramlintide clinical study); has received any investigational drug within 1 month of screening.

How the Study Was Run

Design: randomized, crossover and single-blind.

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.

Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.

In this single-blind Amylin (Islet Amyloid Polypeptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2006-04 with completion listed for 2007-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 12 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.