Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus

Plain-language guide to NCT01137695: phase 3 randomized trial of Amylin (Islet Amyloid Polypeptide), 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01137695
Phase: phase 3
Status: status unknown
Start: 2010-05
Completion (planned or actual): 2012-01
Participants: 40 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).

It had four arms (groups): one (active comparator), one (experimental), one (active comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Age 18-80 years. Type 2 diabetes mellitus. Obese (BMI \> 30 kg/m2), waist circ. \>35" women, \>40" men. Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin. Women of childbearing age if using a reliable form of birth control.

The full record lists 14 inclusion and 26 exclusion criteria; among the exclusions: age \<18 or \>80 years; confirmed gastroparesis or taking medications affecting gastric motility; recurrent severe hypoglycemia or hypoglycemic unawareness.

How the Study Was Run

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

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.

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

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

It started in 2010-05 with completion listed for 2012-01.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucose control (time frame: 6 months).

It also tracked 4 secondary outcomes, for example Weight loss, glucagon level and adverse effects.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amylin (Islet Amyloid Polypeptide) in 40 people.

Its status is unknown; 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.

Our Notes on the Compound

Amylin (Islet Amyloid Polypeptide): A 37-amino-acid hormone released with insulin that slows stomach emptying and signals fullness; pramlintide (Symlin) is a synthetic version.

Amylin (Islet Amyloid Polypeptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.