Phase 3
N=137
Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Treated With Insulin
Bottom Line
View on ClinicalTrials.gov: NCT04460326 ↗Enrolled (actual)
137
Serious AEs
0.8%
Results posted
Mar 2024
Primary outcome: Primary: Postprandial Glucose Control — 36.18; 45.22 percentage of time in range (TIR)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin glargine (Drug); NovoLog (Drug); Insulin Fiasp (Drug); Standard carbohydrate diet (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postprandial Glucose Control |
36.18; 45.22 | — |
| SECONDARY Glycemic Control While Hospitalized |
34.9; 39.9 | — |
| SECONDARY Percent of Time Spent in Glycemic Range of 70-140 mg/dL |
16.9; 20.2 | — |
| SECONDARY Percent of Time Spent With Hypoglycemia During Hospitalization |
0.80; 1.52; 0.16; 0.53; 0.02; 0.10 | — |
| SECONDARY Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL |
36.7; 42.1 | — |
| SECONDARY Percent of Nocturnal Time Spent With Hypoglycemia |
0.52; 1.12; 0.043; 0.22; 0; 0.073 | — |
| SECONDARY Percent of Postprandial Time Spent With Level 1 Hyperglycemia |
30.1; 23.3 | — |
| SECONDARY Percent of Postprandial Time Spent With Level 2 Hyperglycemia |
30.3; 26.7 | — |
| SECONDARY Percent of Postprandial Time Spent With Hypoglycemia |
0.70; 0.76; 0.14; 012; 0.01; 0.03 | — |
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.
Eligibility Criteria
Inclusion criteria
- English-speaking
- Males and female adult subjects admitted to Boston Medical Center to a medical or surgical floor.
- Consultation by the Inpatient Diabetes Service at Boston Medical Center is required prior to consent.
- Age ≥ 21 and 24 hours.
- Use of continuous or intermittent enteral feeding or parenteral nutrition.
- Patient receiving aspirin and/or vitamin C during the hospitalization.
- Any mental condition rendering the subject unable to provide informed consent.
- Patients currently incarcerated.
- Patients using >1 unit/kg/day of insulin prior to admission.
- Insulin pump usage within the 2 weeks prior to or during admission.
- Patients currently using real-time continuous glucose monitoring (CGM) or personal flash glucose monitoring system (FGM).
- Patients with a history of an allergy to any of the types of insulin or one of the excipients in the insulin used in the study.
Data sourced from ClinicalTrials.gov (NCT04460326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.