ClinicalTrials.gov record
Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
ClinicalTrials.gov ID: NCT02058147
Public ClinicalTrials.gov record NCT02058147. 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, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of 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 compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.
Study identification
- NCT ID
- NCT02058147
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,170 participants
Conditions and interventions
Conditions
Interventions
- Insulin glargine/lixisenatide Fixed Ratio Combination Drug
- Insulin glargine (HOE901) Drug
- Lixisenatide (AVE0010) Drug
- Metformin 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
- Feb 2014 (Type not available)
- Primary completion
- Jun 2015 (Actual)
- Completion
- Jun 2015 (Actual)
- Last update posted
- May 9, 2017
2014 – 2015
United States locations
- U.S. sites
- 118
- U.S. states
- 36
- U.S. cities
- 101
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840027 | Phoenix | Arizona | 85028 | — |
| Investigational Site Number 840122 | Phoenix | Arizona | 85032 | — |
| Investigational Site Number 840062 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840023 | Tempe | Arizona | — | — |
| Investigational Site Number 840084 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840100 | Anaheim | California | 92801 | — |
| Investigational Site Number 840065 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840090 | Chino | California | 91710 | — |
| Investigational Site Number 840002 | Chula Vista | California | 91911 | — |
| Investigational Site Number 840013 | Concord | California | 94520 | — |
| Investigational Site Number 840053 | Fresno | California | 93720 | — |
| Investigational Site Number 840017 | La Jolla | California | 92037 | — |
| Investigational Site Number 840070 | Lancaster | California | 93534 | — |
| Investigational Site Number 840121 | Long Beach | California | 90806 | — |
| Investigational Site Number 840126 | Los Angeles | California | 90017 | — |
| Investigational Site Number 840044 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840101 | Mission Hills | California | 91345 | — |
| Investigational Site Number 840086 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840120 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840005 | Northridge | California | 91325 | — |
| Investigational Site Number 840034 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840074 | Port Hueneme | California | 93041 | — |
| Investigational Site Number 840068 | San Ramon | California | 94583 | — |
| Investigational Site Number 840067 | Santa Ana | California | 92704 | — |
| Investigational Site Number 840029 | Tarzana | California | 91356 | — |
| Investigational Site Number 840006 | Temecula | California | 92591 | — |
| Investigational Site Number 840078 | West Hills | California | 91345 | — |
| Investigational Site Number 840059 | Aurora | Colorado | 80045 | — |
| Investigational Site Number 840038 | Denver | Colorado | 80246 | — |
| Investigational Site Number 840104 | Bradenton | Florida | 34208 | — |
| Investigational Site Number 840098 | Miami | Florida | 33156-7563 | — |
| Investigational Site Number 840014 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840047 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840056 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840089 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 840054 | Lawrenceville | Georgia | 30046 | — |
| Investigational Site Number 840119 | Woodstock | Georgia | 30189 | — |
| Investigational Site Number 840108 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840075 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 840080 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 840026 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840116 | Chicago | Illinois | 60616 | — |
| Investigational Site Number 840050 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840008 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840015 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840076 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840082 | Evansville | Indiana | 47713 | — |
| Investigational Site Number 840031 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840060 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840048 | Indianapolis | Indiana | 46202 | — |
| Investigational Site Number 840085 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840012 | Valparaiso | Indiana | — | — |
| Investigational Site Number 840025 | Waterloo | Iowa | 50702 | — |
| Investigational Site Number 840022 | Lexington | Kentucky | 40504 | — |
| Investigational Site Number 840007 | Louisville | Kentucky | 40213 | — |
| Investigational Site Number 840081 | New Orleans | Louisiana | 70112 | — |
| Investigational Site Number 840097 | Auburn | Maine | 04210 | — |
| Investigational Site Number 840063 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840028 | Bloomfield Hills | Michigan | — | — |
| Investigational Site Number 840071 | Chesterfield | Michigan | 48047 | — |
| Investigational Site Number 840001 | Dearborn | Michigan | 48124 | — |
| Investigational Site Number 840091 | Kalamazoo | Michigan | 49048 | — |
| Investigational Site Number 840009 | Minneapolis | Minnesota | 55416 | — |
| Investigational Site Number 840024 | Chesterfield | Missouri | 63017 | — |
| Investigational Site Number 840057 | Butte | Montana | 59701 | — |
| Investigational Site Number 840042 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840109 | Henderson | Nevada | 89052 | — |
| Investigational Site Number 840052 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840069 | Nashua | New Hampshire | 03063 | — |
| Investigational Site Number 840123 | Morganville | New Jersey | 07751 | — |
| Investigational Site Number 840011 | Albuquerque | New Mexico | 87131 | — |
| Investigational Site Number 840030 | New Hyde Park | New York | 11042 | — |
| Investigational Site Number 840096 | Syracuse | New York | 13214-2016 | — |
| Investigational Site Number 840039 | Asheville | North Carolina | 28803 | — |
| Investigational Site Number 840021 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 840046 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 840072 | Morganton | North Carolina | 28655 | — |
| Investigational Site Number 840110 | Salisbury | North Carolina | 28144 | — |
| Investigational Site Number 840095 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840099 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 840004 | Columbus | Ohio | 43213 | — |
| Investigational Site Number 840016 | Maumee | Ohio | 43537 | — |
| Investigational Site Number 840103 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 840113 | Portland | Oregon | 97201-3098 | — |
| Investigational Site Number 840036 | Pittsburgh | Pennsylvania | 15473 | — |
| Investigational Site Number 840043 | Tipton | Pennsylvania | 16684 | — |
| Investigational Site Number 840058 | Anderson | South Carolina | 29621 | — |
| Investigational Site Number 840127 | Charleston | South Carolina | 29407 | — |
| Investigational Site Number 840049 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840114 | Rapid City | South Dakota | 57701 | — |
| Investigational Site Number 840112 | Bristol | Tennessee | 37620 | — |
| Investigational Site Number 840094 | Knoxville | Tennessee | 37912 | — |
| Investigational Site Number 840051 | Austin | Texas | 78758 | — |
| Investigational Site Number 840066 | Corpus Christi | Texas | 78404 | — |
| Investigational Site Number 840111 | Dallas | Texas | 75208 | — |
| Investigational Site Number 840020 | Dallas | Texas | 75216 | — |
| Investigational Site Number 840064 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840003 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840088 | Edinburg | Texas | 78539 | — |
| Investigational Site Number 840118 | Fort Worth | Texas | 76132 | — |
| Investigational Site Number 840055 | Houston | Texas | 77004 | — |
| Investigational Site Number 840087 | Houston | Texas | 77030 | — |
| Investigational Site Number 840079 | Hurst | Texas | 76054 | — |
| Investigational Site Number 840073 | N Richland Hill | Texas | 76180 | — |
| Investigational Site Number 840019 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840037 | Draper | Utah | 84020 | — |
| Investigational Site Number 840093 | Ogden | Utah | 84405 | — |
| Investigational Site Number 840061 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 840041 | Salt Lake City | Utah | 84107 | — |
| Investigational Site Number 840040 | Chesapeake | Virginia | 23321 | — |
| Investigational Site Number 840045 | Norfolk | Virginia | 23510 | — |
| Investigational Site Number 840092 | Norfolk | Virginia | 23510 | — |
| Investigational Site Number 840125 | Richmond | Virginia | 23219 | — |
| Investigational Site Number 840115 | Salem | Virginia | 24153 | — |
| Investigational Site Number 840010 | Weber City | Virginia | 24290 | — |
| Investigational Site Number 840077 | Federal Way | Washington | 98003 | — |
| Investigational Site Number 840102 | Renton | Washington | 98055 | — |
| Investigational Site Number 840033 | 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 155 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02058147, 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 18, 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 NCT02058147 live on ClinicalTrials.gov.