Exenatide for Stress Hyperglycemia

Plain-language guide to NCT01969149: phase 2, phase 3 randomized trial of Exenatide and Insulin (regular human), 110 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01969149
Phase: phase 2, phase 3
Status: completed
Start: 2015-01
Completion (planned or actual): 2015-12
Participants: 110 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Stress Hyperglycemia
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2, phase 3 trial tested Exenatide and Insulin (regular human).

Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients.

It had two arms (groups): Exenatide group (experimental) and Insulin group (active comparator).

The registry classes the interventions as drug.

More on the Plan

A nested cohort study will concern the 24 first patients included in the study (12 patients/group) to assess the impact of a continuous intravenous infusion of exenatide on post operative glycemic variability after planned CABG surgery.

Who Took Part

110 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age over 18. Non insulin requiring type 2 diabetic patients. Non diabetic patients. Planned coronary artery bypass graft (CABG) surgery. ASA (American Society of Anesthesiologists) score 1, 2, or 3.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: pregnancy and breast feeding; acute pancreatitis; chronic pancreatitis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

The Exenatide group and the comparison group ran side by side rather than switching.

Being open-label, the Exenatide study did not mask who received what.

It started in 2015-01 with completion listed for 2015-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Hypoglycemia, Severe hypoglycemia, Number of patients needing rescue to insulin therapy protocol, Number of adverse events occuring in the exenatide group, Mortality and Postoperative morbidity.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide and Insulin (regular human) in 110 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Insulin (regular human) compound page, all human trials.

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 (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

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