Phase 4 · Exenatide

NCT00736229 trial results

Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit

Median Glucose Values From Steady State Through 48 Hours or Until Discharge. (mg/dL), 1-48 hours. Exenatide: 132; Moderate: 127; Intensive: 105.

Participants: 40
Status: completed
Completed: 2012-08
Sponsor: Saint Luke's Health System

As posted on ClinicalTrials.gov (NCT00736229), updated at source Nov 20, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00736229 measured first

Median Glucose Values From Steady State Through 48 Hours or Until Discharge.mg/dL · 1-48 hours · median

Exenatiden=40	Moderaten=71	Intensiven=84
132(110 to 157)	127(105 to 161)	105(92 to 128)

Time to Steady Statehours · Start of infusion through 48 hours or until discharge · median

Exenatiden=40	Moderaten=71	Intensiven=84
2.0(1.5 to 5.0)	12.0(7.0 to 15.0)	3.0(1.0 to 5.0)

Side effects by arm

Side effects in NCT00736229

Percent of participants affected, Until hospital discharge or a maximum of 48 hrs, whichever was shorter.. The most common events the registry lists.

Event	Exenatide
Any serious event	10%
Drug failure	7.5%
Vomiting	5%
Hypoglycemia	2.5%

Secondary outcomes

What else it measured

Rates of Hypoglycemia and Severe Hypoglycemiaparticipants · 1-48 hours · number

Measure	Exenatiden=40	Moderaten=71	Intensiven=84
Patients with at least one hypoglycemic episode	4	14	22
Patients with at least one severe episode	0	2	1

Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)participants · 30 days · number

Exenatiden=40
4

The trial

How NCT00736229 was run

The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.

Exenatide: 0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours

Who could join the trial

Inclusion Criteria: * Admission to coronary ICU * Admission blood glucose 140-299 mg/dL * Primary cardiovascular diagnosis by attending physician * Under primary care of cardiology service * Age \> 18 years old * Ventilator independent * Able to provide informed consent Exclusion Criteria: * Admission blood glucose \< 140 or \> 300 mg/dL * Ventilator dependent * Unconscious sedation * Type 1 diabetes * Known pregnancy * Admitted to coronary ICU for right heart cath to measure hemodynamics prior to transplant * Post transplant procedure * Currently enrolled in another clinical trial * Unable to provide informed consent * Creatinine clearance \< 30 mL/min * On insulin treatment except for monotherapy with long-acting basal insulin (e.g., insulin glargine \[Lantus®\] or detemir \[Levemir®\]) * Gastroparesis

Published papers

Papers from NCT00736229

Abuannadi M, Kosiborod M, Riggs L, House JA, Hamburg MS, Kennedy KF, Marso SP. Management of hyperglycemia with the administration of intravenous exenatide to patients in the cardiac intensive care unit. Endocr Pract. 2013 Jan-Feb;19(1):81-90. doi: 10.4158/EP12196.OR.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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