Coronary Artery DiseasePhase 4SITACABG NonDMNCT02443402
Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery
A Phase 4 study testing Sitagliptin, Regular Human Insulin and Insulin glargine in people with Coronary Artery Disease, run by Emory University at 4 sites in United States.
Trial summary
The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sitagliptin, Regular Human Insulin and Insulin glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
- No previous history of diabetes
- No previous history of hyperglycemia
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital - Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery
The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.
Read the detailed description
About 80% of patients develop high glucose after cardiac surgery. High glucose is linked to an increased risk of hospital complications. High glucose increases the risk of wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. This study will determine if sitagliptin can prevent the development of high glucose after heart surgery. Sitagliptin is a diabetes pill approved by the Food and Drug Administration (FDA) to treat patients with diabetes.
- Conditions
- Coronary Artery Disease
- Being tested
- Sitagliptin, Placebo, Regular Human Insulin, Insulin glargine, Supplemental insulin (Insulin lispro)
- Keywords
- Non diabetic hyperglycemia
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
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
PlaceboDrug
One pill daily until discharge
Regular Human InsulinDrug
Also called Novolin-R, Humulin-R
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.
Insulin glargineDrug
Also called Lantus (glargine)
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:
- If fasting and pre-dinner BG is between 100 - 180 mg/dL in the absence of hypoglycemia the previous day: no change
- If fasting and pre-dinner BG is between 180 - 240 mg/dL in the absence of hypoglycemia: increase glargine by 10% every day
- If fasting and pre-dinner BG is > 241 mg/dL in the absence of hypoglycemia the previous day: increase glargine dose by 20% every day
- If fasting and pre-dinner BG is < 100 mg/dL in the absence of hypoglycemia: stop glargine
Supplemental insulin (Insulin lispro)Drug
Also called Humalog
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:
- BG between 181-220 mg/dL; 2-4 units of insulin lispro
- BG between 221-260 mg/dL; 3-5 units of insulin lispro
- BG between 261-300 mg/dL; 4-6 units of insulin lispro
- BG between 301-350 mg/dL; 5-7 units of insulin lispro
- BG between 351-400 mg/dL; 6-8 units of insulin lispro
- BG > 400 mg/dL; 7-9 units of insulin lispro
Supplemental insulin (Insulin aspart)Drug
Also called Novolog
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:
- BG between 181-220 mg/dL; 2-4 units of insulin aspart
- BG between 221-260 mg/dL; 3-5 units of insulin aspart
- BG between 261-300 mg/dL; 4-6 units of insulin aspart
- BG between 301-350 mg/dL; 5-7 units of insulin aspart
- BG between 351-400 mg/dL; 6-8 units of insulin aspart
- BG > 400 mg/dL; 7-9 units of insulin aspart
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | 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. Receives: Drug: Sitagliptin; Drug: Regular Human Insulin; Drug: Insulin glargine; Drug: Supplemental insulin (Insulin lispro); Drug: Supplemental insulin (Insulin aspart) |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Regular Human Insulin; Drug: Insulin glargine; Drug: Supplemental insulin (Insulin lispro); Drug: Supplemental insulin (Insulin aspart) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
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.
Measured: Post-Surgery (Up to 4 Days)
Number of Subjects With Persistent Hyperglycemia
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)
Measured: Post-Surgery (Up to 10 Days)
Secondary outcomes (26)
Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.
Measured: Post-Surgery (Up to 4 Days)
Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
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.
Measured: Post-Surgery (Up to 4 Days)
Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
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.
Measured: Post-Surgery (Up to 4 Days)
Duration of Continuous Intravenous Insulin (CII)
Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.
Measured: Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
Mean Units Subcutaneous (SQ) Insulin Required
Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).
Measured: Post-Surgery (Up to 10 Days)
Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
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.
Measured: Post-Surgery (Up to 4 Days)
Total Insulin Therapy in the Intensive Care Unit (ICU)
Total amount of insulin glargine insulin (units) administered in the ICU per day.
Measured: Post-Surgery (Up to 4 Days)
Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.
Measured: Post-Surgery (Up to 4 Days)
Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
Number of participants with blood glucose (BG) >180 after transition from ICU.
Measured: Post-Surgery (Up to 10 Days)
Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
Number of participants with blood glucose (BG) <70 during ICU stay.
Measured: Post-Surgery (Up to 4 Days)
Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
Number of participants with blood glucose (BG) <70 after transition from ICU.
Measured: Post-Surgery (Up to 4 Days)
Number of Participants With Blood Glucose Less Than 40 mg/dl
Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.
Measured: Duration of Hospitalization (Up to 30 Days)
Hospital Mortality Rate
The total number of subject deaths during hospital stay will be recorded.
Measured: Post-Surgery (Up to 10 Days)
Intensive Care Unit (ICU) Mortality Rate
The total number of subject deaths during ICU stay will be recorded.
Measured: Post-Surgery (Up to 4 Days)
Number of Participants With Cerebrovascular Events
Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.
Measured: Post-Hospital Discharge (Up to 10 Days)
Hospital Complication Rate
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.
Measured: Duration of Hospitalization (Up to 30 days)
Length of Stay: Intensive Care Unit (ICU)
Number of days in the ICU after coronary artery bypass graft surgery (CABG).
Measured: Post-Surgery (Up to 4 Days)
Length of Hospital Stay After Study Randomization
Number of days in the hospital after a participant is randomized to a study intervention.
Measured: Post-Randomization (Up to 9 days)
Number of Participants Re-admitted to the Hospital Due to Wound Infections
Number of subjects readmitted to the hospital within 30 days due to wound infection.
Measured: Post-Hospital Discharge (Up to 30 Days)
Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.
Measured: Post-Hospital Discharge (Up to 30 Days)
Number of Participants With Emergency Room (ER) Visits
Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.
Measured: Post-Hospital Discharge (Up to 30 Days)
Number of Participants With Infections Not Requiring Hospital Re-admission
Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.
Measured: Post-Hospital Discharge (Up to 30 Days)
Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
The number of subjects requiring the use of inotropes for >24 hours post CABG.
Measured: Post-Surgery (Up to 2 Days)
Number of Subjects Requiring Re-intubation
The number of subjects requiring re-intubation after CABG.
Measured: Post-Surgery (Up to 2 Days)
Number of Subjects Requiring Re-intubation Within 24 Hours
The number of subjects requiring re-intubation with 24 after CABG.
Measured: Post-Surgery (Up to 24 Hours)
Number of Subject Requiring Surgical Re-Intervention
The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.
Measured: Post-Surgery (Up to 10 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443402
- Sponsor's protocol ID
- IRB00080209
- Acronym
- SITACABG NonDM
- Status last verified
- Jan 2018
- First submitted
- 11 May 2015
- Last updated
- 6 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02443402
- Acronym / sponsor ID
- SITACABG NonDM / IRB00080209
- Conditions
- Coronary Artery Disease
- Keywords
- Non diabetic hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Posted 6 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.
Detailed description
About 80% of patients develop high glucose after cardiac surgery. High glucose is linked to an increased risk of hospital complications. High glucose increases the risk of wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. This study will determine if sitagliptin can prevent the development of high glucose after heart surgery. Sitagliptin is a diabetes pill approved by the Food and Drug Administration (FDA) to treat patients with diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: Sitagliptin, Drug: Regular Human Insulin, Drug: Insulin glargine, Drug: Supplemental insulin (Insulin lispro), Drug: Supplemental insulin (Insulin aspart)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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Regular Human Insulin, Drug: Insulin glargine, Drug: Supplemental insulin (Insulin lispro), Drug: Supplemental insulin (Insulin aspart)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
- No previous history of diabetes
- No previous history of hyperglycemia
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: JanuviaSubjects 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 | Drug | Sitagliptin |
| PlaceboOne pill daily until discharge | Drug | Placebo |
| Regular Human InsulinAlso: Novolin-R, Humulin-RContinuous 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. | Drug | Placebo, Sitagliptin |
| Insulin glargineAlso: Lantus (glargine)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: * If fasting and pre-dinner BG is between 100 - 180 mg/dL in the absence of hypoglycemia the previous day: no change * If fasting and pre-dinner BG is between 180 - 240 mg/dL in the absence of hypoglycemia: increase glargine by 10% every day * If fasting and pre-dinner BG is > 241 mg/dL in the absence of hypoglycemia the previous day: increase glargine dose by 20% every day * If fasting and pre-dinner BG is < 100 mg/dL in the absence of hypoglycemia: stop glargine | Drug | Placebo, Sitagliptin |
| Supplemental insulin (Insulin lispro)Also: HumalogInsulin 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: * BG between 181-220 mg/dL; 2-4 units of insulin lispro * BG between 221-260 mg/dL; 3-5 units of insulin lispro * BG between 261-300 mg/dL; 4-6 units of insulin lispro * BG between 301-350 mg/dL; 5-7 units of insulin lispro * BG between 351-400 mg/dL; 6-8 units of insulin lispro * BG > 400 mg/dL; 7-9 units of insulin lispro | Drug | Placebo, Sitagliptin |
| Supplemental insulin (Insulin aspart)Also: NovologInsulin 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: * BG between 181-220 mg/dL; 2-4 units of insulin aspart * BG between 221-260 mg/dL; 3-5 units of insulin aspart * BG between 261-300 mg/dL; 4-6 units of insulin aspart * BG between 301-350 mg/dL; 5-7 units of insulin aspart * BG between 351-400 mg/dL; 6-8 units of insulin aspart * BG > 400 mg/dL; 7-9 units of insulin aspart | Drug | Placebo, Sitagliptin |
Primary outcome
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.
Number of Subjects With Persistent Hyperglycemia
Time frame: Post-Surgery (Up to 10 Days)
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)
26 secondary outcomes
Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
Time frame: Post-Surgery (Up to 4 Days)
Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
Time frame: Post-Surgery (Up to 4 Days)
Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
Time frame: Post-Surgery (Up to 4 Days)
Duration of Continuous Intravenous Insulin (CII)
Time frame: Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
Mean Units Subcutaneous (SQ) Insulin Required
Time frame: 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)
Total Insulin Therapy in the Intensive Care Unit (ICU)
Time frame: Post-Surgery (Up to 4 Days)
Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
Time frame: Post-Surgery (Up to 4 Days)
Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
Time frame: Post-Surgery (Up to 10 Days)
Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
Time frame: Post-Surgery (Up to 4 Days)
Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
Time frame: 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)
Hospital Mortality Rate
Time frame: Post-Surgery (Up to 10 Days)
Intensive Care Unit (ICU) Mortality Rate
Time frame: Post-Surgery (Up to 4 Days)
Number of Participants With Cerebrovascular Events
Time frame: Post-Hospital Discharge (Up to 10 Days)
Hospital Complication Rate
Time frame: Duration of Hospitalization (Up to 30 days)
Length of Stay: Intensive Care Unit (ICU)
Time frame: Post-Surgery (Up to 4 Days)
Length of Hospital Stay After Study Randomization
Time frame: Post-Randomization (Up to 9 days)
Number of Participants Re-admitted to the Hospital Due to Wound Infections
Time frame: Post-Hospital Discharge (Up to 30 Days)
Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
Time frame: Post-Hospital Discharge (Up to 30 Days)
Number of Participants With Emergency Room (ER) Visits
Time frame: Post-Hospital Discharge (Up to 30 Days)
Number of Participants With Infections Not Requiring Hospital Re-admission
Time frame: Post-Hospital Discharge (Up to 30 Days)
Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
Time frame: Post-Surgery (Up to 2 Days)
Number of Subjects Requiring Re-intubation
Time frame: Post-Surgery (Up to 2 Days)
Number of Subjects Requiring Re-intubation Within 24 Hours
Time frame: Post-Surgery (Up to 24 Hours)
Number of Subject Requiring Surgical Re-Intervention
Time frame: Post-Surgery (Up to 10 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin, Regular Human Insulin and Insulin glargine in people with Coronary Artery Disease, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU) (time frame: Post-Surgery (Up to 4 Days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.