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NCT04460326 · ClinicalTrials.gov registry record · Phase 3
Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
NCT04460326: Completed Phase 3 study, sponsored by Boston Medical Center.
NCT04460326 is a Phase 3 study that has completed, run by Boston Medical Center. The registered enrollment target is 137 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04460326, a Phase 3 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Insulin glargine
- OTHER Standard carbohydrate diet
- DRUG NovoLog
- DRUG Insulin Fiasp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2023-05-27 |
| Phase | Phase 3 |
What the finished NCT04460326 record still lists
NCT04460326 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Insulin glargine is the first listed.
NCT04460326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04460326 about?
NCT04460326 is a clinical study titled "Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus". 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...
What is the current status of trial NCT04460326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2020-12-07. Estimated completion is 2023-05-27.
What interventions are being tested in trial NCT04460326?
The interventions under investigation include: Insulin glargine (DRUG), Standard carbohydrate diet (OTHER), NovoLog (DRUG), Insulin Fiasp (DRUG).
Who is sponsoring clinical trial NCT04460326?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04460326's enrollment target sits among peer trials
137 1580th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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