Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

What Was Tested

This registered phase 1, phase 2 trial tested Amylin (Islet Amyloid Polypeptide).

At the same time, poorly controlled hyperglycemia affects negatively graft function and survival as well as on the ability of the immunocompromised host to fight infections.

It had three arms (groups): Standard diabetes therapy (no intervention), Oral diabetic agents and pramlintide (active comparator) and Insulin injection with pramlintide (active comparator).

Standard diabetes therapy with either oral agents or insulin injections.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 20 years up to 70 years.

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

Examples of who could join: Post-transplant diabetes (PTMD). Diagnosis of diabetes within the last 6-18 months. Stable weight for 3 months.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: pre-transplant diabetes; major postoperative complications following transplant; inability to learn continuous glucose monitoring.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Amylin (Islet Amyloid Polypeptide) and who got the comparison, which limits bias.

The Amylin (Islet Amyloid Polypeptide) group and the comparison group ran side by side rather than switching.

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 2009-08 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HgA1c (time frame: 6 months).

It also tracked 1 secondary outcome, for example Continuous glucose monitoring.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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.