Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

Summary

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

Conditions

• Hyperglycemia

Interventions

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

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Maya Fayfman, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2017-04-30

Completion

2017-04-30

Countries

• United States

Study Locations