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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: Completed Phase 3 study, sponsored by Sanofi.
NCT03211858 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 597 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained fro
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 |
What the finished NCT03211858 record still lists
NCT03211858 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Insulin aspart is the first listed.
NCT03211858 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03211858's enrollment target sits among peer trials
597 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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