Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04460326 | Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 137 | — | — | Dec 7, 2020 | May 27, 2023 | Mar 19, 2024 | 1 | United States |
Percent of time spent in the glycemic target range of 100-180 mg/dL in the 4 hour postprandial period will be assessed using a continuous glucose monitoring (CGM) system.
| Arm | Type | Description |
|---|---|---|
| Group 1 insulin glargine and Novolog | ACTIVE_COMPARATOR | Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal blood glucose (BG) is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care. |
| Group 2 insulin glargine and Fiasp | EXPERIMENTAL | Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin. |
| Name | Type | Description |
|---|---|---|
| Insulin glargine | DRUG | Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in \>10% |
| NovoLog | DRUG | Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor. |
| Insulin Fiasp | DRUG | Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor. |
| Standard carbohydrate diet | OTHER | Standard carbohydrate diet as per usual hospital care (75g with each meal) |
Inclusion criteria 1. English-speaking 2. Males and female adult subjects admitted to Boston Medical Center to a medical or surgical floor. 3. Consultation by the Inpatient Diabetes Service at Boston Medical Center is required prior to consent. 4. Age ≥ 21 and \<= 80 years. 5. Diagnosed with type 2...