Trial Outcomes & Findings for Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients (NCT NCT00736229)

NCT ID: NCT00736229

Last Updated: 2014-11-20

Results Overview

Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 1-48 hours
• Results posted on: 2014-11-20

Participant Flow

Recruitment start: October 2008 Enrollment complete: June 2010 Recruitment location: Coronary Intensive Care Unit at Saint Luke's Hospital of Kansas City All eligible patients providing informed consent were assigned to a single group: exenatide infusion

All glucose lowering medications were discontinued prior to infusion of exenatide to study the relation between exenatide and blood glucose.

Participant milestones

Measure	Exenatide Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.	Moderate In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose \>180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.	Intensive In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose \>140 mg/dL admitted prior to protocol implementation.
Overall Study STARTED	40	71	84
Overall Study COMPLETED	40	71	84
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Baseline characteristics by cohort

Measure	Exenatide n=40 Participants Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.	Moderate n=71 Participants In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose \>180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.	Intensive n=84 Participants In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose \>140 mg/dL admitted prior to protocol implementation.	Total n=195 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	41 Participants n=4 Participants	45 Participants n=27 Participants	107 Participants n=483 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants	30 Participants n=4 Participants	39 Participants n=27 Participants	88 Participants n=483 Participants
Age, Continuous	65 years STANDARD_DEVIATION 11.9 • n=93 Participants	64 years STANDARD_DEVIATION 11.5 • n=4 Participants	64 years STANDARD_DEVIATION 13.7 • n=27 Participants	64.18 years STANDARD_DEVIATION 12.5 • n=483 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	26 Participants n=4 Participants	32 Participants n=27 Participants	65 Participants n=483 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	45 Participants n=4 Participants	52 Participants n=27 Participants	130 Participants n=483 Participants
Region of Enrollment United States	40 participants n=93 Participants	71 participants n=4 Participants	84 participants n=27 Participants	195 participants n=483 Participants

PRIMARY outcome

Timeframe: 1-48 hours

Population: Intention to treat

Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.

Outcome measures

Measure	Exenatide n=40 Participants Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.	Moderate n=71 Participants In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose \>180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.	Intensive n=84 Participants In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose \>140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
Median Glucose Values From Steady State Through 48 Hours or Until Discharge.	132 mg/dL Interval 110.0 to 157.0	127 mg/dL Interval 105.0 to 161.0	105 mg/dL Interval 92.0 to 128.0

PRIMARY outcome

Timeframe: Start of infusion through 48 hours or until discharge

Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl.

Outcome measures

Measure	Exenatide n=40 Participants Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.	Moderate n=71 Participants In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose \>180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.	Intensive n=84 Participants In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose \>140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
Time to Steady State	2.0 hours Interval 1.5 to 5.0	12.0 hours Interval 7.0 to 15.0	3.0 hours Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 1-48 hours

Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl)

Outcome measures

Measure	Exenatide n=40 Participants Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.	Moderate n=71 Participants In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose \>180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.	Intensive n=84 Participants In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose \>140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
Rates of Hypoglycemia and Severe Hypoglycemia Patients with at least one hypoglycemic episode	4 participants	14 participants	22 participants
Rates of Hypoglycemia and Severe Hypoglycemia Patients with at least one severe episode	0 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Exenatide n=40 Participants Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.	Moderate In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose \>180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.	Intensive In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose \>140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)	4 participants	—	—

Adverse Events

Exenatide

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exenatide n=40 participants at risk Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
Cardiac disorders Death	7.5% 3/40 • Number of events 3 • Until hospital discharge or a maximum of 48 hrs, whichever was shorter. Patients were continually monitored from study drug start until discharge to collect serious and other adverse events.
Vascular disorders Stroke	2.5% 1/40 • Number of events 1 • Until hospital discharge or a maximum of 48 hrs, whichever was shorter. Patients were continually monitored from study drug start until discharge to collect serious and other adverse events.

Other adverse events

Measure	Exenatide n=40 participants at risk Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
Gastrointestinal disorders Vomiting	5.0% 2/40 • Number of events 2 • Until hospital discharge or a maximum of 48 hrs, whichever was shorter. Patients were continually monitored from study drug start until discharge to collect serious and other adverse events.
Metabolism and nutrition disorders Drug failure	7.5% 3/40 • Number of events 3 • Until hospital discharge or a maximum of 48 hrs, whichever was shorter. Patients were continually monitored from study drug start until discharge to collect serious and other adverse events.
Metabolism and nutrition disorders Hypoglycemia	2.5% 1/40 • Number of events 1 • Until hospital discharge or a maximum of 48 hrs, whichever was shorter. Patients were continually monitored from study drug start until discharge to collect serious and other adverse events.

Additional Information

Steven P. Marso, MD

Saint Luke's Health System

Phone: 816-932-5773

Email: smarso@saint-lukes.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place