Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA(1c): The FREEDOM-1 HBL (High Baseline) Study

What Was Tested

The paper reports a study of Exenatide, published as a randomized controlled trial.

ITCA 650 is a subdermal osmotic mini-pump that continuously delivers exenatide subcutaneously for 3-6 months.

Who Took Part

The study group was 3 patients.

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

How the Study Was Run

The design is described as randomized, double-blind, open-label and placebo-controlled.

The patients were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Blinding on both sides kept the patients and researchers unaware of who received Exenatide.

Nothing was hidden in this open-label Exenatide study: the patients and staff both knew the treatment.

A placebo (an inactive look-alike) gave the Exenatide group a baseline to be compared against.

The primary end point was change in HbA1c at week 39.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Body Mass Index, Diabetes Mellitus, Type 2, Exenatide, Glycated Hemoglobin, Hyperglycemia and Hypoglycemic Agents.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Exenatide in 3 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (Diabetes care), a journal based in United States.

More context: the Exenatide compound page, all human trials.