A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT02688933. 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
A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus. Secondary Objective: To demonstrate that treatment with HOE901-U300 compared to Lantus provides: * Lower incidence rate of nocturnal symptomatic hypoglycemia; * Better glucose control coverage during the last hours of CGM before next basal-insulin dosing; * Less variability in CGM profile.
Study identification
- NCT ID
- NCT02688933
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 638 participants
Conditions and interventions
Conditions
Interventions
- HOE901-U300 (Insulin Glargine 300 U/ml) Drug
- Lantus (Insulin Glargine 100 U/ml) Drug
- Mandated back ground therapy Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- 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
- May 4, 2016
- Primary completion
- Jun 18, 2017
- Completion
- Jun 18, 2017
- Last update posted
- Mar 27, 2022
2016 – 2017
United States locations
- U.S. sites
- 99
- U.S. states
- 29
- U.S. cities
- 83
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840-151 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840-071 | Concord | California | 94520-2270 | — |
| Investigational Site Number 840-149 | Escondido | California | 92025 | — |
| Investigational Site Number 840-004 | Fresno | California | 93720 | — |
| Investigational Site Number 840-110 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840-124 | La Jolla | California | 92037 | — |
| Investigational Site Number 840-030 | La Mesa | California | 91942 | — |
| Investigational Site Number 840-044 | Los Angeles | California | 90036 | — |
| Investigational Site Number 840-022 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840-129 | Los Gatos | California | 95032 | — |
| Investigational Site Number 840-024 | Northridge | California | 91325 | — |
| Investigational Site Number 840-069 | Pomona | California | 91766 | — |
| Investigational Site Number 840-090 | Pomona | California | 91767 | — |
| Investigational Site Number 840-132 | Rolling Hills Estates | California | 90274 | — |
| Investigational Site Number 840-130 | San Jose | California | 95148 | — |
| Investigational Site Number 840-055 | San Ramon | California | 94583 | — |
| Investigational Site Number 840-028 | Santa Barbara | California | — | — |
| Investigational Site Number 840-063 | Tarzana | California | 91356 | — |
| Investigational Site Number 840-138 | Tustin | California | 92780-6953 | — |
| Investigational Site Number 840-016 | Ventura | California | 93003 | — |
| Investigational Site Number 840-039 | Denver | Colorado | 80209 | — |
| Investigational Site Number 840-021 | Denver | Colorado | 80246 | — |
| Investigational Site Number 840-070 | Denver | Colorado | 80262 | — |
| Investigational Site Number 840-046 | Englewood | Colorado | 80113 | — |
| Investigational Site Number 840-072 | Coral Gables | Florida | 33124 | — |
| Investigational Site Number 840-133 | Hialeah | Florida | 33016 | — |
| Investigational Site Number 840-137 | Maitland | Florida | 32751 | — |
| Investigational Site Number 840-049 | Miami | Florida | 33155 | — |
| Investigational Site Number 840-076 | Miami | Florida | 33176 | — |
| Investigational Site Number 840-023 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840-053 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840-112 | Ormond Beach | Florida | 32174 | — |
| Investigational Site Number 840-018 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840-047 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 840-114 | Tampa | Florida | 33612 | — |
| Investigational Site Number 840-036 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 840-001 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 840-064 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 840-012 | Lawrenceville | Georgia | 30046 | — |
| Investigational Site Number 840-008 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840-014 | Stockbridge | Georgia | 30281 | — |
| Investigational Site Number 840-060 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840-125 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 840-011 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840-134 | Crystal Lake | Illinois | 60012 | — |
| Investigational Site Number 840-002 | West Des Moines | Iowa | 50265 | — |
| Investigational Site Number 840-073 | Wichita | Kansas | 67226 | — |
| Investigational Site Number 840-062 | Covington | Kentucky | 41011 | — |
| Investigational Site Number 840-042 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 840-009 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840-032 | New Orleans | Louisiana | 70115 | — |
| Investigational Site Number 840-054 | Hyattsville | Maryland | 20782 | — |
| Investigational Site Number 840-006 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840-157 | Framingham | Massachusetts | 01702 | — |
| Investigational Site Number 840-122 | Waltham | Massachusetts | 02453 | — |
| Investigational Site Number 840-037 | Flint | Michigan | 48532 | — |
| Investigational Site Number 840-067 | Billings | Montana | 59101 | — |
| Investigational Site Number 840-094 | Lincoln | Nebraska | 68526 | — |
| Investigational Site Number 840-033 | Omaha | Nebraska | 68114 | — |
| Investigational Site Number 840-142 | Omaha | Nebraska | 68124 | — |
| Investigational Site Number 840-040 | Henderson | Nevada | 89052 | — |
| Investigational Site Number 840-017 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840-102 | New York | New York | 10001 | — |
| Investigational Site Number 840-108 | New York | New York | 10029 | — |
| Investigational Site Number 840-109 | Staten Island | New York | 10301-3914 | — |
| Investigational Site Number 840-045 | Greenville | North Carolina | 27834 | — |
| Investigational Site Number 840-010 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 840-080 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 840-051 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840-123 | Columbus | Ohio | 43203 | — |
| Investigational Site Number 840-104 | Mentor | Ohio | 44060 | — |
| Investigational Site Number 840-079 | Norman | Oklahoma | 73069 | — |
| Investigational Site Number 840-162 | Bend | Oregon | 97702 | — |
| Investigational Site Number 840-096 | Portland | Oregon | 97210 | — |
| Investigational Site Number 840-058 | Chattanooga | Tennessee | 37411 | — |
| Investigational Site Number 840-003 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840-019 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840-075 | Dallas | Texas | 75235 | — |
| Investigational Site Number 840-005 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840-013 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840-153 | El Paso | Texas | 79925 | — |
| Investigational Site Number 840-026 | Fort Worth | Texas | 76132 | — |
| Investigational Site Number 840-081 | Houston | Texas | 77024 | — |
| Investigational Site Number 840-160 | Houston | Texas | 77043 | — |
| Investigational Site Number 840-156 | Houston | Texas | 77079 | — |
| Investigational Site Number 840-152 | Houston | Texas | 77089 | — |
| Investigational Site Number 840-031 | Houston | Texas | 77095 | — |
| Investigational Site Number 840-140 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 840-029 | Mesquite | Texas | 75149 | — |
| Investigational Site Number 840-048 | North Richland Hills | Texas | 76180 | — |
| Investigational Site Number 840-150 | Pearland | Texas | 77584 | — |
| Investigational Site Number 840-083 | Murray | Utah | 84123 | — |
| Investigational Site Number 840-101 | Ogden | Utah | 84405 | — |
| Investigational Site Number 840-097 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 840-143 | Bennington | Vermont | 05201 | — |
| Investigational Site Number 840-056 | Burlington | Vermont | 05405 | — |
| Investigational Site Number 840-015 | Renton | Washington | 98055 | — |
| Investigational Site Number 840-074 | Spokane | Washington | 99207 | — |
| Investigational Site Number 840-139 | 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02688933, 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 27, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02688933 live on ClinicalTrials.gov.