Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Public ClinicalTrials.gov record NCT03211858. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03211858
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 597 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2, 2017 (Actual)
- Primary completion
- Jul 16, 2018 (Actual)
- Completion
- Jan 12, 2019 (Actual)
- Last update posted
- Mar 28, 2022
2017 – 2019
United States locations
- U.S. sites
- 42
- U.S. states
- 22
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400040 | Little Rock | Arkansas | 72211 | — |
| Investigational Site Number 8400012 | Concord | California | 94520 | — |
| Investigational Site Number 8400002 | Escondido | California | 92025 | — |
| Investigational Site Number 8400030 | Fresno | California | 93720 | — |
| Investigational Site Number 8400004 | Greenbrae | California | 94904 | — |
| Investigational Site Number 8400014 | La Jolla | California | 92037 | — |
| Investigational Site Number 8400043 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8400036 | Pomona | California | 91766 | — |
| Investigational Site Number 8400011 | Santa Barbara | California | 93105 | — |
| Investigational Site Number 8400013 | Ventura | California | 93003 | — |
| Investigational Site Number 8400037 | Aurora | Colorado | 80045 | — |
| Investigational Site Number 8400018 | Englewood | Colorado | 80113 | — |
| Investigational Site Number 8400031 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 8400027 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8400007 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 8400022 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 8400032 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 8400038 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 8400005 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 8400041 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 8400015 | Rockville | Maryland | 20852-4267 | — |
| Investigational Site Number 8400042 | Waltham | Massachusetts | 02453 | — |
| Investigational Site Number 8400019 | Flint | Michigan | 48532-3447 | — |
| Investigational Site Number 8400003 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 8400024 | Henderson | Nevada | 89052 | — |
| Investigational Site Number 8400028 | New York | New York | 10001 | — |
| Investigational Site Number 8400025 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 8400010 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 8400023 | Fargo | North Dakota | 58104 | — |
| Investigational Site Number 8400029 | Bend | Oregon | 97701 | — |
| Investigational Site Number 8400033 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 8400044 | Austin | Texas | 78731 | — |
| Investigational Site Number 8400009 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8400035 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8400021 | Dallas | Texas | 75246 | — |
| Investigational Site Number 8400017 | Houston | Texas | 77043 | — |
| Investigational Site Number 8400001 | Houston | Texas | 77079 | — |
| Investigational Site Number 8400020 | Houston | Texas | 77089 | — |
| Investigational Site Number 8400016 | Mesquite | Texas | 75149 | — |
| Investigational Site Number 8400034 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 8400008 | Renton | Washington | 98057 | — |
| Investigational Site Number 8400039 | Bridgeport | West Virginia | 26330 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03211858, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03211858 live on ClinicalTrials.gov.