A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes

What Was Tested

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

ITCA 650 is an investigational new drug that provides continuous subcutaneous delivery of exenatide.

Who Took Part

According to the abstract, 650 patients were involved.

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

How the Study Was Run

In design terms this was a randomized, open-label and multicenter study.

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

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

Running at several centres spread the Exenatide study over different clinics and patient groups.

Plasma glucose, HbA1c, insulin, and weight were measured at regular intervals throughout the study.

Exenatide levels and anti-exenatide antibodies were also assessed.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 2, Exenatide, Glucagon-Like Peptide-1 Receptor, Glycated Hemoglobin, Hypoglycemic Agents and Peptides.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Exenatide and Glucagon in 650 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2013 (Clinical therapeutics), a journal based in United States.

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