Continuous Subcutaneous Infusion of Pramlintide and Insulin

What Was Tested

This registered phase 4 trial tested Amylin (Islet Amyloid Polypeptide).

The registry classes the interventions as drug.

More on the Plan

However, the possibility of low blood sugars still remains.

Low blood sugars the major limiting factor in gaining "tight" control of blood sugar.

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

There is a lack of insulin and failure of glucagon to work correctly in diabetes.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 13 years up to 22 years.

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

Examples of who could join: 13-22 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 23 years or less than 13 years at the time of study; lack of a supportive family environment; positive pregnancy test in menstruating young women.

How the Study Was Run

The set-up was randomized, crossover 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.

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

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.

It started in 2006-01 with completion listed for 2007-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve for glucose (time frame: 4 hrs).

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

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Amylin (Islet Amyloid Polypeptide) in 13 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.