Status:
COMPLETED
Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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 \<= 80 years.
- Diagnosed with type 2 diabetes at least 180 days prior to screening.
- Hyperglycemia during admission, as defined by a point of care and/or venous blood glucose ≥ 140 mg/dL.
- Prior to admission subjects must be using one of the following for outpatient diabetes management:
- Insulin
- ≥ 2 oral/injectable agents
- One oral/injectable agent with a hemoglobin A1c of ≥ 8% within 3 months of enrollment.
- Patients who are expected to remain hospitalized for a minimum of 48 hours following CGM sensor placement.
- BMI \<45 kg/m\^2.
- Subjects must have insulin glargine dosing planned at bedtime for the duration of the study period. Morning and afternoon dosing of insulin glargine are exclusionary.
- Exclusion criteria:
- Patients with a history of type 1 diabetes or late-onset autoimmune diabetes (LADA).
- Treatment or plan for treatment with glucocorticoids during the index hospitalization.
- Female patients who are pregnant (tested during hospitalization or screening) or breast-feeding during the hospitalization.
- Patients admitted with the following conditions: diabetic ketoacidosis, hyperosmolar hyperglycemic state, solid organ transplantation, or coronary artery bypass surgery.
- Prior diagnosis of gastroparesis or cirrhosis.
- Acute or chronic kidney disease with a serum creatinine of ≥ 2 mg/dL at the time of screening.
- Clinically significant nausea and/or vomiting or unable to consume more than 30 grams of carbohydrate at each meal.
- Patients expected to receive nothing by mouth (NPO) for \>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.
Exclusion
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2023
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04460326
Start Date
December 7 2020
End Date
May 27 2023
Last Update
March 19 2024
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118