Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04075513 · ClinicalTrials.gov registry record · Phase 4
Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 343
- Enrollment target
NCT04075513 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 343 participants.
The verdict
NCT04075513, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 343 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus. Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring. To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.
Interventions
- DRUG Insulin glargine, 300 U/ml
- DRUG Insulin degludec, 100U/ml
- DRUG Background therapy: Rapid acting insulin analogs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04075513
The ClinicalTrials.gov registry entry for NCT04075513 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine, 300 U/ml is the first listed.
NCT04075513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04075513 about?
NCT04075513 is a clinical study titled "Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients". Primary Objective: To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus. Secondary Objective: To evaluate the glycemic control and variability pa...
What is the current status of trial NCT04075513?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 343 participants. The study started on 2019-10-09. Estimated completion is 2021-09-16.
What interventions are being tested in trial NCT04075513?
The interventions under investigation include: Insulin glargine, 300 U/ml (DRUG), Insulin degludec, 100U/ml (DRUG), Background therapy: Rapid acting insulin analogs (DRUG).
Who is sponsoring clinical trial NCT04075513?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.