Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Public ClinicalTrials.gov record NCT02320721. 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, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change
Study identification
- NCT ID
- NCT02320721
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,014 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 65 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
- May 2016 (Actual)
- Completion
- May 2016 (Actual)
- Last update posted
- Apr 21, 2020
2015 – 2016
United States locations
- U.S. sites
- 64
- U.S. states
- 24
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840058 | Saraland | Alabama | 36571 | — |
| Investigational Site Number 840019 | Fresno | California | 93720 | — |
| Investigational Site Number 840021 | Fresno | California | 93722 | — |
| Investigational Site Number 840040 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840070 | Huntington Park | California | 90255 | — |
| Investigational Site Number 840064 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840031 | Norwalk | California | 90650 | — |
| Investigational Site Number 840065 | Oakland | California | 94612 | — |
| Investigational Site Number 840050 | Orange | California | 92868 | — |
| Investigational Site Number 840036 | Simi Valley | California | 93065 | — |
| Investigational Site Number 840003 | Temecula | California | 92591 | — |
| Investigational Site Number 840062 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 840027 | Longmont | Colorado | 80501 | — |
| Investigational Site Number 840030 | Bradenton | Florida | 34208 | — |
| Investigational Site Number 840010 | Miami | Florida | 33156 | — |
| Investigational Site Number 840035 | Miami | Florida | 33156 | — |
| Investigational Site Number 840014 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840051 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840056 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840007 | St. Petersburg | Florida | — | — |
| Investigational Site Number 840041 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840053 | Statesboro | Georgia | 30461 | — |
| Investigational Site Number 840042 | Woodstock | Georgia | 30189 | — |
| Investigational Site Number 840005 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 840004 | Peoria | Illinois | 61602 | — |
| Investigational Site Number 840029 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840013 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840023 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840039 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840006 | Muncie | Indiana | 47304 | — |
| Investigational Site Number 840026 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840033 | West Des Moines | Iowa | 50266 | — |
| Investigational Site Number 840032 | Overland Park | Kansas | 66209 | — |
| Investigational Site Number 840069 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840020 | Flint | Michigan | 48504 | — |
| Investigational Site Number 840037 | Nashua | New Hampshire | 03063 | — |
| Investigational Site Number 840018 | New York | New York | 10001 | — |
| Investigational Site Number 840048 | Asheville | North Carolina | 28805 | — |
| Investigational Site Number 840009 | Charlotte | North Carolina | 28209 | — |
| Investigational Site Number 840011 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 840047 | Greenville | North Carolina | 27834 | — |
| Investigational Site Number 840016 | Salisbury | North Carolina | 28144 | — |
| Investigational Site Number 840012 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840022 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840072 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840054 | Wadsworth | Ohio | 44281 | — |
| Investigational Site Number 840067 | Bend | Oregon | 97702 | — |
| Investigational Site Number 840057 | Corvallis | Oregon | 97330 | — |
| Investigational Site Number 840045 | Feasterville | Pennsylvania | 19053 | — |
| Investigational Site Number 840017 | Pittsburgh | Pennsylvania | 15220 | — |
| Investigational Site Number 840059 | Greenville | South Carolina | 29605 | — |
| Investigational Site Number 840015 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840002 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840046 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840034 | Knoxville | Tennessee | 37912 | — |
| Investigational Site Number 840055 | Arlington | Texas | 76014 | — |
| Investigational Site Number 840001 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840024 | Irving | Texas | 75039 | — |
| Investigational Site Number 840061 | North Richland Hills | Texas | 76180 | — |
| Investigational Site Number 840028 | Richmond | Texas | 77469 | — |
| Investigational Site Number 840063 | San Antonio | Texas | 78230 | — |
| Investigational Site Number 840038 | St. George | Utah | 84790 | — |
| Investigational Site Number 840025 | Federal Way | Washington | 98003 | — |
| Investigational Site Number 840060 | 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 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02320721, 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 Apr 21, 2020 · Synced Oct 22, 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 NCT02320721 live on ClinicalTrials.gov.