A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).

Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion.

Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.

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

The registry classes the interventions as drug.

More on the Plan

You will not be permitted to participate in the study if you have taken pramlintide (Symlin) during the previous three months.

The study will consist of seven visits to the Study Center over a four-month period.

Subjects will undergo meal tolerance testing at beginning and end of study period.

Continuous blood glucose monitoring will be performed on three occasions during the study.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Treated with CSII therapy for at least 6 months;. Age 18 to 70 years, inclusive;. BMI ≤35 kg/m2;. If female, has a negative urine pregnancy test at screening;. If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study;.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator;; if female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant;; has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months;.

How the Study Was Run

The set-up was single-group and open-label.

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 2007-07 with completion listed for 2008-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction and Hemoglobin A1c.

What This Means in Plain Language

Put simply, this is a phase 4 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.