Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Treated With Insulin
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Hyperglycemia affects 30-40% of hospitalized patients. Despite the fact that basal/bolus
      insulin therapy has been demonstrated to improve glycemic control and clinical outcomes in
      patients, achieving good glucose control remains a challenge.

      This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after
      meals compared to another type of insulin known as Novolog. The study will be performed in
      patients with type 2 diabetes admitted to the hospital, who are not in the intensive care
      unit, and who are being seen by the inpatient diabetes consult team. Eligible participants
      will be treated with Fiasp or Novolog injected multiple times a day before meals and at
      bedtime, in addition to a once daily injection of insulin glargine as basal insulin. Which
      type of meal time insulin (Fiasp vs Novolog) the subject gets is decided by chance, like the
      flip of a coin. Insulin doses will be started and titrated based on a protocol. All the
      subjects will wear a blinded continuous glucose monitoring (CGM)) sensor placed in their arm
      which they will wear for 72 hours during the study. The glucose values from the CGM,
      collected during the time it is worn, will be downloaded and compared to assess the response
      to the two different types of insulins - Fiasp and Novolog. The goal is to determine if Fiasp
      works as well as or better than Novolog in controlling blood sugars, particularly after
      meals, in the subjects of the study.
    


Intervention name(s): Insulin glargine; NovoLog; Insulin Fiasp; Standard carbohydrate diet
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 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 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.; 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 as per usual hospital care (75g with each meal)
Other intervention name(s): Lantus®; NovoLog®; Fiasp®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fiasp; Novolog; Continuous glucose monitor (CGM); Hypoglycemia; Hyperglycemia; Hemoglobin A1c