- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443402
Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (SITACABG NonDM)
Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital
-
Atlanta, Georgia, United States, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, United States, 30303
- Grady Health System
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Atlanta, Georgia, United States, 30308
- Emory University Hospital - Midtown
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
- No previous history of diabetes
- No previous history of hyperglycemia
Exclusion Criteria:
- Patients with hyperglycemia (blood glucose > 125 mg/dL); or glycated hemoglobin (HbA1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin
- Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR < 30 mL/min) or clinically significant hepatic failure
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
- Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction
- Patients with clinically relevant pancreatic or gallbladder disease
- Treatment with oral or injectable corticosteroid
- Mental condition rendering the subject unable to understand the scope, and consequences of the study
- Female subjects who are pregnant or breast feeding at time of enrollment into the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sitagliptin
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin.
Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.
Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
|
Subjects will take one pill daily until the day prior to them being discharged from the hospital.
Sitagliptin will be dispensed orally at 100 mg/day and at a lower dose 50 mg for patients with glomerular filtration rate (GFR) < 30-50.
If the calculated GFR drops to 30 mL/min/1.73m2
or below, patients will receive study medication 25mg daily
Other Names:
Continuous intravenous insulin given to ICU patients with a BG > 180 mg/DL for two consecutive readings and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.
Intravenous insulin infusion will be continued until the patient is able to eat and/or transferred to non-ICU service.
In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3
U/day.
Other Names:
When regular insulin is discontinued, if needed, insulin glargine will be given once daily. Patients who required continuous insulin infusion at an average rate >2U/h will be transitioned to basal (to be given approx. 4 hours prior to discontinuing the insulin drip) starting at a dose 0.2 U/Kg/d. Subjects with a BG at 140-200 mg/dL will start glargine at 0.2 U/kg weight per day. And subjects with BG between 201-400 mg/dL will start glargine at 0.2 U/Kg/day The basal insulin dose will be adjusted as follow:
Other Names:
Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given. For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
Other Names:
Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given. For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
Other Names:
|
Placebo Comparator: Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo.
Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.
Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
|
Continuous intravenous insulin given to ICU patients with a BG > 180 mg/DL for two consecutive readings and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.
Intravenous insulin infusion will be continued until the patient is able to eat and/or transferred to non-ICU service.
In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3
U/day.
Other Names:
When regular insulin is discontinued, if needed, insulin glargine will be given once daily. Patients who required continuous insulin infusion at an average rate >2U/h will be transitioned to basal (to be given approx. 4 hours prior to discontinuing the insulin drip) starting at a dose 0.2 U/Kg/d. Subjects with a BG at 140-200 mg/dL will start glargine at 0.2 U/kg weight per day. And subjects with BG between 201-400 mg/dL will start glargine at 0.2 U/Kg/day The basal insulin dose will be adjusted as follow:
Other Names:
Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given. For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
Other Names:
Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given. For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
Other Names:
One pill daily until discharge
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 4 Days)
|
Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.
|
Post-Surgery (Up to 4 Days)
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Number of Subjects With Persistent Hyperglycemia
Time Frame: Post-Surgery (Up to 10 Days)
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Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)
|
Post-Surgery (Up to 10 Days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
Time Frame: Post-Surgery (Up to 4 Days)
|
Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.
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Post-Surgery (Up to 4 Days)
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Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
Time Frame: Post-Surgery (Up to 4 Days)
|
The blood glucose levels will be assessed throughout the day using a glucose meter.
An average will be calculated.
The normal BG range for someone with diabetes is 80-130 mg/dL.
|
Post-Surgery (Up to 4 Days)
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Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 4 Days)
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The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU.
The more insulin given, the more hyperglycemic events experienced.
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Post-Surgery (Up to 4 Days)
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Duration of Continuous Intravenous Insulin (CII)
Time Frame: Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
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Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.
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Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
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Mean Units Subcutaneous (SQ) Insulin Required
Time Frame: Post-Surgery (Up to 10 Days)
|
Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).
|
Post-Surgery (Up to 10 Days)
|
Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 4 Days)
|
The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU.
The normal BG range for someone with diabetes is 80-130 mg/dL.
|
Post-Surgery (Up to 4 Days)
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Total Insulin Therapy in the Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 4 Days)
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Total amount of insulin glargine insulin (units) administered in the ICU per day.
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Post-Surgery (Up to 4 Days)
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Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
Time Frame: Post-Surgery (Up to 4 Days)
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Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.
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Post-Surgery (Up to 4 Days)
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Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 10 Days)
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Number of participants with blood glucose (BG) >180 after transition from ICU.
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Post-Surgery (Up to 10 Days)
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Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
Time Frame: Post-Surgery (Up to 4 Days)
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Number of participants with blood glucose (BG) <70 during ICU stay.
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Post-Surgery (Up to 4 Days)
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Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 4 Days)
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Number of participants with blood glucose (BG) <70 after transition from ICU.
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Post-Surgery (Up to 4 Days)
|
Number of Participants With Blood Glucose Less Than 40 mg/dl
Time Frame: Duration of Hospitalization (Up to 30 Days)
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Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.
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Duration of Hospitalization (Up to 30 Days)
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Hospital Mortality Rate
Time Frame: Post-Surgery (Up to 10 Days)
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The total number of subject deaths during hospital stay will be recorded.
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Post-Surgery (Up to 10 Days)
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Intensive Care Unit (ICU) Mortality Rate
Time Frame: Post-Surgery (Up to 4 Days)
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The total number of subject deaths during ICU stay will be recorded.
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Post-Surgery (Up to 4 Days)
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Number of Participants With Cerebrovascular Events
Time Frame: Post-Hospital Discharge (Up to 10 Days)
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Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.
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Post-Hospital Discharge (Up to 10 Days)
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Hospital Complication Rate
Time Frame: Duration of Hospitalization (Up to 30 days)
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The total number of all complications experienced during hospitalization.
Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.
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Duration of Hospitalization (Up to 30 days)
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Length of Stay: Intensive Care Unit (ICU)
Time Frame: Post-Surgery (Up to 4 Days)
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Number of days in the ICU after coronary artery bypass graft surgery (CABG).
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Post-Surgery (Up to 4 Days)
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Length of Hospital Stay After Study Randomization
Time Frame: Post-Randomization (Up to 9 days)
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Number of days in the hospital after a participant is randomized to a study intervention.
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Post-Randomization (Up to 9 days)
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Number of Participants Re-admitted to the Hospital Due to Wound Infections
Time Frame: Post-Hospital Discharge (Up to 30 Days)
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Number of subjects readmitted to the hospital within 30 days due to wound infection.
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Post-Hospital Discharge (Up to 30 Days)
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Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
Time Frame: Post-Hospital Discharge (Up to 30 Days)
|
Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.
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Post-Hospital Discharge (Up to 30 Days)
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Number of Participants With Emergency Room (ER) Visits
Time Frame: Post-Hospital Discharge (Up to 30 Days)
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Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.
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Post-Hospital Discharge (Up to 30 Days)
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Number of Participants With Infections Not Requiring Hospital Re-admission
Time Frame: Post-Hospital Discharge (Up to 30 Days)
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Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.
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Post-Hospital Discharge (Up to 30 Days)
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Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
Time Frame: Post-Surgery (Up to 2 Days)
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The number of subjects requiring the use of inotropes for >24 hours post CABG.
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Post-Surgery (Up to 2 Days)
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Number of Subjects Requiring Re-intubation
Time Frame: Post-Surgery (Up to 2 Days)
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The number of subjects requiring re-intubation after CABG.
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Post-Surgery (Up to 2 Days)
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Number of Subjects Requiring Re-intubation Within 24 Hours
Time Frame: Post-Surgery (Up to 24 Hours)
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The number of subjects requiring re-intubation with 24 after CABG.
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Post-Surgery (Up to 24 Hours)
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Number of Subject Requiring Surgical Re-Intervention
Time Frame: Post-Surgery (Up to 10 Days)
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The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.
|
Post-Surgery (Up to 10 Days)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin Glargine
- Insulin Lispro
- Sitagliptin Phosphate
Other Study ID Numbers
- IRB00080209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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