Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03874715 · ClinicalTrials.gov registry record · Phase 3
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
NCT03874715 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 210 participants.
The verdict
NCT03874715, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: * To compare the effects of alternating administration of SAR341402 and NovoLog with continuous use of NovoLog on immunogenicity. * To evaluate the safety of alternating administration of SAR341402 and NovoLog versus continuous use of NovoLog. * To compare other PK parameters between the two treatment arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog).
Interventions
- DRUG Insulin Aspart
- DRUG Insulin Aspart SAR341402
- DRUG Insulin glargine U100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03874715
The ClinicalTrials.gov registry entry for NCT03874715 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 210 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 Aspart is the first listed.
NCT03874715 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03874715 about?
NCT03874715 is a clinical study titled "Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine". Primary Objective: To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine...
What is the current status of trial NCT03874715?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2019-03-11. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT03874715?
The interventions under investigation include: Insulin Aspart (DRUG), Insulin Aspart SAR341402 (DRUG), Insulin glargine U100 (DRUG).
Who is sponsoring clinical trial NCT03874715?
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.