Sitagliptin in Non-Diabetic Patients Undergoing General Surgery
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare sitagliptin with a placebo for the prevention of high
      glucose after general surgery.
    

Detailed description: 
      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.
    

Intervention name(s): Sitagliptin; Placebo; Supplemental insulin (insulin lispro); Supplemental insulin (insulin aspart); Long acting basal insulin (insulin detemir); Long acting basal insulin (insulin glargine)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; Participants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.; 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:
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 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:
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; 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:
Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change
Fasting and pre-meal BG between >180-240 mg/dl: increase detemir or glargine dose by 10% every day
Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight; 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:
Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change
Fasting and pre-meal BG between >180-240 mg/dl: increase detemir or glargine dose by 10% every day
Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight
Other intervention name(s): Januvia; Humalog; NovoLog; Levemir; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Sitagliptin Phosphate; Insulin Aspart; Insulin Lispro; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: stress hyperglycemia; blood glucose