Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Amylin (Islet Amyloid Polypeptide).

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 400 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

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 2003-04 with completion listed for 2005-06.

It ran at 48 sites in United States (48).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus (time frame: 6 months). Understand management issues in subjects with type 1 and type 2 diabetes mellitus (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Amylin (Islet Amyloid Polypeptide) in 400 people.

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.