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NCT02273180 · ClinicalTrials.gov registry record · Phase 3
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin 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
- 507
- Enrollment target
NCT02273180 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 507 participants.
The verdict
NCT02273180, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.
Interventions
- DRUG Humalog
- DRUG SAR342434
- DRUG Insulin glargine HOE901
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02273180
The ClinicalTrials.gov registry entry for NCT02273180 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 507 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 Humalog is the first listed.
NCT02273180 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02273180 about?
NCT02273180 is a clinical study titled "Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine". Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and H...
What is the current status of trial NCT02273180?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2014-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02273180?
The interventions under investigation include: Humalog (DRUG), SAR342434 (DRUG), Insulin glargine HOE901 (DRUG).
Who is sponsoring clinical trial NCT02273180?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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