226
Participants
Start Date
October 31, 2015
Primary Completion Date
December 11, 2019
Study Completion Date
December 11, 2019
Insulin glargine
"Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day.~Daily insulin dose will be adjusted as follow:~* If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change~* If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day~* If the fasting and pre-dinner BG is \>180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day~* If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day~* If a patient develops hypoglycemia (BG \<70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%."
Insulin aspart
"Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held.~Daily insulin dose will be adjusted as follow:~* If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change~* If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day~* If the fasting and pre-dinner BG is \>180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day~* If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day~* If a patient develops hypoglycemia (BG \<70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%."
Supplemental insulin aspart
"Insulin aspart will be administered following the supplemental insulin scale protocol.~For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:~* BG \>141-180 mg/dL; 2-4 units of insulin aspart~* BG between 181-220 mg/dL; 3-6 units of insulin aspart~* BG between 221-260 mg/dL; 4-8 units of insulin aspart~* BG between 261-300 mg/dL; 5-10 units of insulin aspart~* BG between 301-350 mg/dL; 6-12 units of insulin aspart~* BG between 351-400 mg/dL; 7-14 units of insulin aspart~* BG \> 400 mg/dL; 8-16 units of insulin aspart~For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:~* BG between 261-300 mg/dL; 5-10 units of insulin aspart~* BG between 301-350 mg/dL; 6-12 units of insulin aspart~* BG between 351-400 mg/dL; 7-14 units of insulin aspart~* BG \> 400 mg/dL; 8-16 units of insulin aspart"
Grady Memorial Hospital, Atlanta
Emory University Hospital, Atlanta
Emory University
OTHER