ClinicalTrials.gov record
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02058160
Public ClinicalTrials.gov record NCT02058160. 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, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.
Study identification
- NCT ID
- NCT02058160
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 736 participants
Conditions and interventions
Conditions
Interventions
- Insulin glargine/lixisenatide (HOE901/AVE0010) Drug
- Insulin glargine (HOE901) Drug
- Metformin (Background Drug) Drug
Drug
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 2014 (Type not available)
- Primary completion
- Jul 2015 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- May 9, 2017
2014 – 2015
United States locations
- U.S. sites
- 108
- U.S. states
- 34
- U.S. cities
- 94
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840607 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 840570 | Sun City | Arizona | 85351 | — |
| Investigational Site Number 840562 | Tempe | Arizona | — | — |
| Investigational Site Number 840577 | Tucson | Arizona | 85723 | — |
| Investigational Site Number 840517 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840537 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840568 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840550 | Chino | California | 91710 | — |
| Investigational Site Number 840529 | Chula Vista | California | 91911 | — |
| Investigational Site Number 840623 | Corona | California | 92879 | — |
| Investigational Site Number 840566 | Fresno | California | 93720 | — |
| Investigational Site Number 840552 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840578 | Lancaster | California | 93534 | — |
| Investigational Site Number 840626 | Los Angeles | California | 90017 | — |
| Investigational Site Number 840581 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840621 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840511 | Northridge | California | 91325 | — |
| Investigational Site Number 840573 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840559 | Port Hueneme | California | 93041 | — |
| Investigational Site Number 840536 | San Ramon | California | 94583 | — |
| Investigational Site Number 840567 | Santa Ana | California | 92704 | — |
| Investigational Site Number 840569 | Tarzana | California | 91356 | — |
| Investigational Site Number 840572 | West Hills | California | 91345 | — |
| Investigational Site Number 840582 | Aurora | Colorado | 80045 | — |
| Investigational Site Number 840509 | Denver | Colorado | 80246 | — |
| Investigational Site Number 840549 | Wilmington | Delaware | 19713 | — |
| Investigational Site Number 840510 | Miami | Florida | 33156-7563 | — |
| Investigational Site Number 840521 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840602 | Ocala | Florida | 34471 | — |
| Investigational Site Number 840538 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840534 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840594 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 840614 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 840501 | Lawrenceville | Georgia | 30046 | — |
| Investigational Site Number 840525 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840588 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840580 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 840519 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 840612 | Chicago | Illinois | 60616 | — |
| Investigational Site Number 840556 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840543 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840565 | Evansville | Indiana | 47713 | — |
| Investigational Site Number 840585 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840615 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840563 | Indianapolis | Indiana | 46202 | — |
| Investigational Site Number 840507 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840516 | Louisville | Kentucky | 40213 | — |
| Investigational Site Number 840595 | Lewiston | Maine | 04240 | — |
| Investigational Site Number 840520 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840560 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840522 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840505 | Dearborn | Michigan | 48124 | — |
| Investigational Site Number 840575 | Flint | Michigan | 48504 | — |
| Investigational Site Number 840564 | Minneapolis | Minnesota | 55416 | — |
| Investigational Site Number 840558 | Butte | Montana | 59701 | — |
| Investigational Site Number 840506 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840600 | Henderson | Nevada | 89074 | — |
| Investigational Site Number 840532 | Las Vegas | Nevada | 89119 | — |
| Investigational Site Number 840599 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840539 | Nashua | New Hampshire | 03063 | — |
| Investigational Site Number 840576 | Albuquerque | New Mexico | 87131 | — |
| Investigational Site Number 840583 | Jamaica | New York | 11432 | — |
| Investigational Site Number 840531 | New Hyde Park | New York | 11042 | — |
| Investigational Site Number 840557 | Syracuse | New York | 13214-2016 | — |
| Investigational Site Number 840541 | Durham | North Carolina | 27710 | — |
| Investigational Site Number 840604 | Greenville | North Carolina | 27858 | — |
| Investigational Site Number 840540 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 840513 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 840592 | Salisbury | North Carolina | 28144 | — |
| Investigational Site Number 840535 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840515 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 840579 | Columbus | Ohio | 43213 | — |
| Investigational Site Number 840524 | Dayton | Ohio | 45439 | — |
| Investigational Site Number 840503 | Maumee | Ohio | 43537 | — |
| Investigational Site Number 840618 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 840610 | Philadelphia | Pennsylvania | 19107 | — |
| Investigational Site Number 840551 | Smithfield | Pennsylvania | 15478 | — |
| Investigational Site Number 840584 | Tipton | Pennsylvania | 16684 | — |
| Investigational Site Number 840622 | Charleston | South Carolina | 29407 | — |
| Investigational Site Number 840611 | Rapid City | South Dakota | 57701 | — |
| Investigational Site Number 840605 | Amarillo | Texas | 79106 | — |
| Investigational Site Number 840553 | Austin | Texas | 78731 | — |
| Investigational Site Number 840598 | Austin | Texas | 78731 | — |
| Investigational Site Number 840502 | Corpus Christi | Texas | 78404 | — |
| Investigational Site Number 840601 | Dallas | Texas | 75208 | — |
| Investigational Site Number 840586 | Dallas | Texas | 75216 | — |
| Investigational Site Number 840547 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840530 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840545 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840554 | Edinburg | Texas | 78539 | — |
| Investigational Site Number 840544 | Houston | Texas | 77030 | — |
| Investigational Site Number 840514 | Hurst | Texas | 76054 | — |
| Investigational Site Number 840617 | N Richland Hill | Texas | 76180 | — |
| Investigational Site Number 840512 | Draper | Utah | 84020 | — |
| Investigational Site Number 840591 | Murray | Utah | 84123 | — |
| Investigational Site Number 840526 | Ogden | Utah | 84405 | — |
| Investigational Site Number 840597 | Orem | Utah | 84058 | — |
| Investigational Site Number 840590 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 840613 | Burlington | Vermont | 05401 | — |
| Investigational Site Number 840504 | Chesapeake | Virginia | 23321 | — |
| Investigational Site Number 840561 | Norfolk | Virginia | 23510 | — |
| Investigational Site Number 840625 | Norfolk | Virginia | 23510 | — |
| Investigational Site Number 840606 | Richmond | Virginia | 23227 | — |
| Investigational Site Number 840608 | Salem | Virginia | 24153 | — |
| Investigational Site Number 840571 | Federal Way | Washington | 98003 | — |
| Investigational Site Number 840593 | Spokane | Washington | 99220 | — |
| Investigational Site Number 840609 | Tacoma | Washington | 98415-0299 | — |
| Investigational Site Number 840546 | 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 128 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02058160, 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 May 9, 2017 · Synced Oct 25, 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 NCT02058160 live on ClinicalTrials.gov.