Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy

What Was Tested

The paper reports a study of Amylin (Islet Amyloid Polypeptide), published as a randomized controlled trial.

This study was designed to assess diabetes-related distress and its association with clinical outcomes in patients with type 2 diabetes using basal insulin who were treated with pramlintide.

Hierarchical, stepwise multiple regression was used to assess the association of clinical outcomes and during-trial hypoglycemia with DDS score changes during the study.

Who Took Part

The study group was 211 patients.

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

In a 16-week, double-blind, placebo-controlled study 211 patients using insulin glargine with or without oral antidiabetes agents were randomized to addition of pramlintide or placebo.

The DDS assesses overall diabetes distress and four subdomains: regimen distress (RD), emotional burden (EB), interpersonal distress (ID), and physician-related distress (PD).

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

The patients were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

Neither the patients nor the staff measuring them knew who was on Amylin (Islet Amyloid Polypeptide), so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Amylin (Islet Amyloid Polypeptide) group a baseline to be compared against.

What Was Measured

PubMed files the paper under topics including Amyloid, Body Mass Index, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemic Agents, Insulin and Interpersonal Relations.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Amylin (Islet Amyloid Polypeptide) in 211 patients.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2008 (Diabetes technology & therapeutics), a journal based in United States.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.