NCT02741687

Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperglycemia

Interventions

Type	Name	Description
DRUG	Sitagliptin	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.
DRUG	Placebo	Participants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.
DRUG	Supplemental insulin (insulin lispro)	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
DRUG	Supplemental insulin (insulin aspart)	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
DRUG	Long acting basal insulin (insulin detemir)	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
DRUG	Long acting basal insulin (insulin glargine)	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

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-04-18
• Last updated: 2018-06-27
• Results posted: 2018-06-27

Locations

2 sites across 1 country: United States