Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Public ClinicalTrials.gov record NCT02294474. 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 the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
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 hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) 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. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c \<7.0% and \<=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.
Study identification
- NCT ID
- NCT02294474
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 505 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
- Jan 2015 (Type not available)
- Primary completion
- Feb 2016 (Actual)
- Completion
- Feb 2016 (Actual)
- Last update posted
- Jan 18, 2018
2015 – 2016
United States locations
- U.S. sites
- 51
- U.S. states
- 22
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840217 | Foley | Alabama | 36535 | — |
| Investigational Site Number 840237 | Muscle Shoals | Alabama | 35661 | — |
| Investigational Site Number 840245 | Chandler | Arizona | — | — |
| Investigational Site Number 840219 | Phoenix | Arizona | 85028 | — |
| Investigational Site Number 840227 | Phoenix | Arizona | 85050 | — |
| Investigational Site Number 840212 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840241 | El Cajon | California | 92020 | — |
| Investigational Site Number 840238 | Fresno | California | 93720 | — |
| Investigational Site Number 840229 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840231 | Huntington Beach | California | 92648 | — |
| Investigational Site Number 840247 | Long Beach | California | 90807 | — |
| Investigational Site Number 840234 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840235 | Northridge | California | 91325 | — |
| Investigational Site Number 840251 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840249 | Santa Ana | California | 92704 | — |
| Investigational Site Number 840223 | Temecula | California | 92591 | — |
| Investigational Site Number 840259 | Tustin | California | 92780 | — |
| Investigational Site Number 840240 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 840214 | Boynton Beach | Florida | 33472 | — |
| Investigational Site Number 840246 | Miami | Florida | 33176 | — |
| Investigational Site Number 840226 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840205 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840206 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840242 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 840253 | Lawrenceville | Georgia | 30046 | — |
| Investigational Site Number 840207 | Stockbridge | Georgia | 30281 | — |
| Investigational Site Number 840248 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 840204 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840257 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840230 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840239 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840236 | Troy | Michigan | 48085 | — |
| Investigational Site Number 840216 | Lincoln | Nebraska | 68521 | — |
| Investigational Site Number 840220 | Las Vegas | Nevada | 89119 | — |
| Investigational Site Number 840233 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840224 | Linden | New Jersey | — | — |
| Investigational Site Number 840232 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 840211 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 840228 | Morganton | North Carolina | 28655 | — |
| Investigational Site Number 840225 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840221 | Columbus | Ohio | 43201 | — |
| Investigational Site Number 840255 | Dayton | Ohio | 45439 | — |
| Investigational Site Number 840250 | Tipton | Pennsylvania | 16684 | — |
| Investigational Site Number 840243 | Uniontown | Pennsylvania | 15401 | — |
| Investigational Site Number 840208 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840215 | Jackson | Tennessee | 38305 | — |
| Investigational Site Number 840203 | Austin | Texas | 78731 | — |
| Investigational Site Number 840258 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840201 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840222 | Renton | Washington | 98055 | — |
| Investigational Site Number 840209 | 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 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02294474, 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 NCT02294474 live on ClinicalTrials.gov.