Pramlintide in Adolescents With Type 1 Diabetes

What Was Tested

The trial (not phased) is built around Amylin (Islet Amyloid Polypeptide).

This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

It had two arms (groups): 1 Symlin (experimental) and 2 Usual Regimen (no intervention).

The registry classes the interventions as drug.

More on the Plan

Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal.

Meals will be controlled for carbohydrate, fat and protein content.

Meals will be identical at each CTRC visit.

There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 13 years up to 17 years.

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

Examples of who could join: Between 13 and 17 years of age, inclusive. Diagnosed with type 1 diabetes for \> 1 year. Currently using carbohydrate to insulin ratio. Acceptable form of birth control.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: use of oral hyperglycemic agents or medications affecting blood sugar levels; recurrent severe hypoglycemia requiring assistance in past 6 months; history of hypoglycemia unawareness.

How the Study Was Run

The set-up was randomized, parallel-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.

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

Nothing was hidden in this open-label Amylin (Islet Amyloid Polypeptide) study: the participants and staff both knew the treatment.

It started in 2006-12 with completion listed for 2009-12.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: HbA1c Value After 28 Days (time frame: 28).

It also tracked 1 secondary outcome, for example Weight Change After 28 Days Intervention Period.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 10 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.