Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study

What Was Tested

This randomized controlled trial paper looks at Somatostatin and Pasireotide.

The objective of this study was to assess incretin-based therapy versus insulin for managing pasireotide-associated hyperglycemia uncontrolled by metformin/other permitted oral antidiabetic drugs.

The primary objective was to evaluate the difference in mean change in HbA1c from randomization to end of core phase between incretin-based therapy and insulin treatment arms.

Who Took Part

The age groups tagged for this paper are adults.

Multicenter, randomized, open-label, Phase IV study comprising a core phase (≤ 16-week pre-randomization period followed by 16-week randomized treatment period) and optional extension (ClinicalTrials.gov ID: NCT02060383).

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

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

Everyone knew when Somatostatin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the participants came from several places.

What Was Measured

The subject headings attached to it are Blood Glucose, Diabetes Mellitus, Type 2, Hyperglycemia, Hypoglycemic Agents, Pituitary ACTH Hypersecretion and Somatostatin.

The authors tagged it with the keywords Acromegaly, Cushing’s, Incretin-based therapy, Insulin and Pasireotide.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Somatostatin and Pasireotide.

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 2021 (Pituitary), a journal based in United States.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.