← Human Trials & Peer-Reviewed Studies

Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial

Plain-language guide to PMID 16230722 (2005): open-label randomized controlled trial study of Exenatide and Insulin Glargine in 551 patients.

Key Facts

PMID
16230722
Journal
Annals of internal medicine
Year
2005
Study type
Randomized Controlled Trial
Authors
Heine RJ et al. (6 authors)
DOI
10.7326/0003-4819-143-8-200510180-00006
Registered trial
NCT00082381

What This Study Did, in Plain Language

What Was Tested

This randomized controlled trial paper looks at Exenatide and Insulin Glargine.

To compare effects of exenatide and insulin glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea.

Why It Was Studied

Physicians may use either insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs.

The trial was open-label and did not assess clinical complications related to diabetes.

Who Took Part

The abstract describes 551 patients taking part.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

82 outpatient study centers in 13 countries.

How the Study Was Run

The researchers set it up as 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.

26-week multicenter, open-label, randomized, controlled trial.

Hemoglobin A1c level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability.

What Was Measured

The trial was open-label and did not assess clinical complications related to diabetes.

The subject headings attached to it are Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 2, Exenatide, Glycated Hemoglobin, Hypoglycemia and Hypoglycemic Agents.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Exenatide and Insulin Glargine in 551 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 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2005 (Annals of internal medicine), a journal based in United States.

More context: the Exenatide compound page and the Insulin Glargine compound page.

Our Notes on the Compounds

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Related Pages

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