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NCT03211858 · ClinicalTrials.gov registry record · Phase 3
Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 597
- Enrollment target
NCT03211858 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 597 participants.
The verdict
NCT03211858, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 597 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®. Secondary Objectives: * To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study. * To assess the relationship of AIAs with efficacy and safety. * To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (\<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c). * To assess safety of SAR341402 and NovoLog/NovoRapid.
Interventions
- DRUG Insulin aspart
- DRUG Insulin glargine (HOE901)
- DRUG NovoLog/NovoRapid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2019-01-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03211858
The ClinicalTrials.gov registry entry for NCT03211858 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 597 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.
NCT03211858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03211858 about?
NCT03211858 is a clinical study titled "Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine". Primary Objective: To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®. Secondary Objectives: * To assess the immunogenicit...
What is the current status of trial NCT03211858?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 597 participants. The study started on 2017-08-02. Estimated completion is 2019-01-12.
What interventions are being tested in trial NCT03211858?
The interventions under investigation include: Insulin aspart (DRUG), Insulin glargine (HOE901) (DRUG), NovoLog/NovoRapid (DRUG).
Who is sponsoring clinical trial NCT03211858?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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