Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

PHASE4CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

December 11, 2019

Study Completion Date

December 11, 2019

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

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%."

DRUG

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%."

DRUG

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"

Trial Locations (2)

30303

Grady Memorial Hospital, Atlanta

30322

Emory University Hospital, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT02408120 - Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes | Biotech Hunter | Biotech Hunter