Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Public ClinicalTrials.gov record NCT02273180. 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 SAR342434 to Humalog® in Adult Patients With Type 1 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 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.
Study identification
- NCT ID
- NCT02273180
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 507 participants
Conditions and interventions
Conditions
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
- Oct 2014 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- Jul 2016 (Actual)
- Last update posted
- Jan 18, 2018
2014 – 2016
United States locations
- U.S. sites
- 47
- U.S. states
- 21
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840049 | Tucson | Arizona | 85714 | — |
| Investigational Site Number 840016 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840048 | Chula Vista | California | 91910 | — |
| Investigational Site Number 840046 | Concord | California | 94520 | — |
| Investigational Site Number 840039 | Fresno | California | 93720 | — |
| Investigational Site Number 840028 | La Jolla | California | 92037 | — |
| Investigational Site Number 840022 | Ventura | California | 93003 | — |
| Investigational Site Number 840003 | Denver | Colorado | 80209 | — |
| Investigational Site Number 840037 | Denver | Colorado | 80262 | — |
| Investigational Site Number 840005 | Bradenton | Florida | 34208 | — |
| Investigational Site Number 840050 | Miami | Florida | 33155 | — |
| Investigational Site Number 840042 | Miami | Florida | 33176 | — |
| Investigational Site Number 840061 | Miami Lakes | Florida | 33014 | — |
| Investigational Site Number 840057 | Miami Lakes | Florida | 33016 | — |
| Investigational Site Number 840006 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840013 | North Miami Beach | Florida | 33162 | — |
| Investigational Site Number 840031 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 840036 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 840045 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840020 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840019 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 840033 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840012 | McHenry | Illinois | 60050 | — |
| Investigational Site Number 840004 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840043 | Marrero | Louisiana | 70072 | — |
| Investigational Site Number 840021 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840038 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840014 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840060 | Great Falls | Montana | 59405 | — |
| Investigational Site Number 840026 | Omaha | Nebraska | 68114 | — |
| Investigational Site Number 840040 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840015 | Albuquerque | New Mexico | 87106 | — |
| Investigational Site Number 840054 | Albuquerque | New Mexico | 87109 | — |
| Investigational Site Number 840059 | Mineola | New York | 11501 | — |
| Investigational Site Number 840030 | Burlington | North Carolina | 27215 | — |
| Investigational Site Number 840051 | Greenville | North Carolina | 27834 | — |
| Investigational Site Number 840062 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840018 | Gallipolis | Ohio | 45631 | — |
| Investigational Site Number 840007 | Dakota Dunes | South Dakota | 57049 | — |
| Investigational Site Number 840027 | Rapid City | South Dakota | 57701 | — |
| Investigational Site Number 840041 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840029 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840034 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840002 | Houston | Texas | 77090 | — |
| Investigational Site Number 840011 | Chesapeake | Virginia | 23321 | — |
| Investigational Site Number 840023 | Tacoma | Washington | 98415-0299 | — |
| Investigational Site Number 840009 | Milwaukee | Wisconsin | 53209-0996 | — |
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 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02273180, 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 Jan 18, 2018 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02273180 live on ClinicalTrials.gov.