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Clinical Trial Details

Trial ID: L2345
Source ID: NCT04460326
Associated Drug: Insulin Glargine
Title: Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
Acronym: In-FI
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04460326/results
Conditions: Type 2 Diabetes Treated With Insulin
Interventions: DRUG: Insulin glargine|DRUG: NovoLog|DRUG: Insulin Fiasp|OTHER: Standard carbohydrate diet
Outcome Measures: Primary: Postprandial Glucose Control, 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., 3 days | Secondary: Glycemic Control While Hospitalized, Percent of time spent in the glycemic target range of 100-180 mg/dL during the duration of the study will be assessed using a continuous glucose monitoring (CGM) system., 3 days|Percent of Time Spent in Glycemic Range of 70-140 mg/dL, Percent of time spent in the glycemic target range of 70-140 mg/dL during the duration of the study assessed using a continuous glucose monitoring (CGM) system., 3 days|Percent of Time Spent With Hypoglycemia During Hospitalization, The percent of time in three categories of hypoglycemia : \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL will be assessed using a CGM during hospitalization., 3 days|Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL, The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL, 3 days|Percent of Nocturnal Time Spent With Hypoglycemia, The percent of nocturnal time (from 00.01 AM to 5:59 AM) in three categories of hypoglycemia: \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL will be assessed using CGM., 3 days|Percent of Postprandial Time Spent With Level 1 Hyperglycemia, The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period., 4 hours postprandial|Percent of Postprandial Time Spent With Level 2 Hyperglycemia, The percent of time spent in level 2 hyperglycemia (\>240 mg/dL) will be assessed using CGM in the 4 hour postprandial period., 4 hours postprandial|Percent of Postprandial Time Spent With Hypoglycemia, The percent of postprandial time in three categories of hypoglycemia will be assessed: \<70 mg/dL, \<54 mg/dL, and \<40 mg/dL., 4 hours postprandial
Sponsor/Collaborators: Sponsor: Boston Medical Center | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 137
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-12-07
Completion Date: 2023-05-27
Results First Posted: 2024-03-19
Last Update Posted: 2024-03-19
Locations: Boston Medical Center, Boston, Massachusetts, 02118, United States
URL: https://clinicaltrials.gov/show/NCT04460326