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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: Completed Phase 4 study, sponsored by Sanofi.
NCT04075513 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 343 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12.
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 |
What the finished NCT04075513 record still lists
NCT04075513 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine, 300 U/ml is the first listed.
NCT04075513 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04075513's enrollment target sits among peer trials
343 246th of 2000 higher than 1,755 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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