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The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including 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. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.
Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin Arm | Experimental | Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery). Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care. Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale. |
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| Placebo Arm | Placebo Comparator | Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery). Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care. Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Participants will take 100 mg/day for patients with glomerular filtration rate (GFR) > 50 and 50 mg/day for GFR 30 - 49, beginning on the day prior to surgery and continuing through hospitalization, up to 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Stress Hyperglycemia | The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL. | Up to time of discharge from hospital, an average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Supplemental, Subcutaneous Insulin | Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin | Up to time of discharge from hospital, an average of 10 days |
| Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya Fayfman, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital Midtown |
A total of 97 patients consented to be in the study and one participant withdrew prior to randomization. After subsequent failure to meet eligibility criteria (such as surgery being cancelled or postponed) and voluntary participant withdrawals prior to receiving the study medication there were 80 participants who received the study intervention.
Participants were recruited from Emory University Hospital and Grady Hospital in Atlanta, Georgia between June 2016 and March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) |
| FG001 | Sitagliptin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2016 |
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| Placebo | Drug | Participants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days. |
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| Supplemental insulin (insulin lispro) | Drug | Supplemental 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 blood glucose (BG) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level. For subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, the supplemental insulin scale is as follows:
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| Supplemental insulin (insulin aspart) | Drug | Supplemental 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 blood glucose (BG) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level. For subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, the supplemental insulin scale is as follows:
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| Long acting basal insulin (insulin detemir) | Drug | Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
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| Long acting basal insulin (insulin glargine) | Drug | Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
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Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo |
| Up to time of discharge from hospital, an average of 10 days |
| Length of Hospital Stay | Total length of hospital stay | Up to time of discharge from hospital, an average of 10 days |
| Number of Participants With Hypoglycemic Events | Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL) | Up to time of discharge from hospital, an average of 10 days |
| Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization | The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery. | Up to time of discharge from hospital, an average of 10 days |
| Number of Days in the ICU | The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required. | Up to time of discharge from hospital, an average of 10 days |
| Number of Participants With Hospital Readmissions After Discharge | Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known. | Up to 40 days (average time of discharge from the hospital plus 30 days) |
| Number of Participants With Emergency Room Visits After Discharge | Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known. | Up to 40 days (average time of discharge from the hospital plus 30 days) |
| Number of Participants Experiencing Complications | The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented. | Up to 40 days (average time of discharge from the hospital plus 30 days) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
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| NOT COMPLETED |
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The baseline analysis population includes all participants who began the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) |
| BG001 | Sitagliptin | Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Surgery type | Count of Participants | Participants |
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| ASA Status | The American Society of Anesthesiology (ASA) Physical Status Classification is a method of assessing patients prior to surgery. The following categories are used:
| Count of Participants | Participants |
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| Admission blood glucose | Mean | Standard Deviation | mg/dl |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Stress Hyperglycemia | The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL. | Posted | Count of Participants | Participants | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Number of Patients Requiring Supplemental, Subcutaneous Insulin | Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin | Posted | Count of Participants | Participants | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin | Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo | The population for this analysis is limited to participants who received insulin during their hospital stay following surgery. | Posted | Number | international units of insulin | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Length of Hospital Stay | Total length of hospital stay | Posted | Median | Inter-Quartile Range | days | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Number of Participants With Hypoglycemic Events | Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL) | Posted | Count of Participants | Participants | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization | The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery. | Posted | Count of Participants | Participants | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Number of Days in the ICU | The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required. | This analysis includes participants who were transferred to the ICU following surgery. | Posted | Median | Inter-Quartile Range | days | Up to time of discharge from hospital, an average of 10 days |
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| Secondary | Number of Participants With Hospital Readmissions After Discharge | Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known. | Posted | Count of Participants | Participants | Up to 40 days (average time of discharge from the hospital plus 30 days) |
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| Secondary | Number of Participants With Emergency Room Visits After Discharge | Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known. | Posted | Count of Participants | Participants | Up to 40 days (average time of discharge from the hospital plus 30 days) |
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| Secondary | Number of Participants Experiencing Complications | The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented. | Posted | Count of Participants | Participants | Up to 40 days (average time of discharge from the hospital plus 30 days) |
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Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) | 0 | 36 | 1 | 36 | 5 | 36 |
| EG001 | Sitagliptin | Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) | 0 | 44 | 1 | 44 | 8 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Due to anesthesia medication |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | Non-systematic Assessment |
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| Repeat operation | Surgical and medical procedures | Non-systematic Assessment |
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| Tachycardia with anemia | Cardiac disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maya Fayfman, MD | Emory University | 404-778-1664 | maya.fayfman@emory.edu |
| Apr 17, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| D000069057 | Insulin Detemir |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
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| Male |
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| White |
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| Other |
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| Genitourinary |
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| Gastrointestinal |
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| Neurologic |
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| Oral maxillofacial surgery |
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| Thoracic |
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| Burn/Wound |
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| Vascular |
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| gynecologic |
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| ASA status = 2 |
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| ASA status = 3 |
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| Unknown |
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