ClinicalTrials.gov record
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
ClinicalTrials.gov ID: NCT01499095
Public ClinicalTrials.gov record NCT01499095. 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
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
Study identification
- NCT ID
- NCT01499095
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 811 participants
Conditions and interventions
Conditions
Interventions
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
- Nov 30, 2011
- Primary completion
- Mar 31, 2013
- Completion
- Oct 31, 2013
- Last update posted
- Mar 22, 2022
2011 – 2013
United States locations
- U.S. sites
- 110
- U.S. states
- 33
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840517 | Birmingham | Alabama | 35213 | — |
| Investigational Site Number 840149 | Chandler | Arizona | 85224 | — |
| Investigational Site Number 840093 | Glendale | Arizona | 85306 | — |
| Investigational Site Number 840069 | Phoenix | Arizona | 85028 | — |
| Investigational Site Number 840110 | Sun City | Arizona | 85351 | — |
| Investigational Site Number 840068 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840015 | Hot Springs | Arkansas | 71913 | — |
| Investigational Site Number 840014 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840114 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840018 | Mountain Home | Arkansas | 72653 | — |
| Investigational Site Number 840027 | Searcy | Arkansas | 72143 | — |
| Investigational Site Number 840074 | Anaheim | California | 92801 | — |
| Investigational Site Number 840509 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840060 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840057 | La Jolla | California | 92037 | — |
| Investigational Site Number 840003 | La Mesa | California | 91942 | — |
| Investigational Site Number 840026 | Los Angeles | California | 90073 | — |
| Investigational Site Number 840090 | Mission Hills | California | 91345 | — |
| Investigational Site Number 840099 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840004 | San Diego | California | 92161 | — |
| Investigational Site Number 840124 | Santa Barbara | California | 93110 | — |
| Investigational Site Number 840012 | Tustin | California | 92780 | — |
| Investigational Site Number 840104 | Colorado Springs | Colorado | 80906 | — |
| Investigational Site Number 840128 | Colorado Springs | Colorado | 80909 | — |
| Investigational Site Number 840098 | Denver | Colorado | 80206 | — |
| Investigational Site Number 840518 | Brandon | Florida | 33511 | — |
| Investigational Site Number 840049 | Daytona Beach | Florida | 32117 | — |
| Investigational Site Number 840008 | Jacksonville | Florida | 32258 | — |
| Investigational Site Number 840520 | Miami | Florida | 33015 | — |
| Investigational Site Number 840025 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840011 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840141 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840513 | Pembroke Pines | Florida | 33029 | — |
| Investigational Site Number 840528 | Columbus | Georgia | 31901 | — |
| Investigational Site Number 840050 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840107 | Nampa | Idaho | 83686 | — |
| Investigational Site Number 840199 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840021 | McHenry | Illinois | 60050 | — |
| Investigational Site Number 840020 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840045 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840077 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840088 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840089 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840091 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840130 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840142 | Lafayette | Indiana | 47904 | — |
| Investigational Site Number 840041 | Paducah | Kentucky | 42003 | — |
| Investigational Site Number 840034 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840150 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840031 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840063 | Ann Arbor | Michigan | 48106 | — |
| Investigational Site Number 840064 | Dearborn | Michigan | 48124 | — |
| Investigational Site Number 840094 | Flint | Michigan | 48504 | — |
| Investigational Site Number 840023 | Southfield | Michigan | 48034 | — |
| Investigational Site Number 840066 | Eagan | Minnesota | 55122 | — |
| Investigational Site Number 840081 | Minneapolis | Minnesota | 55416 | — |
| Investigational Site Number 840158 | Biloxi | Mississippi | 39531 | — |
| Investigational Site Number 840526 | Chesterfield | Missouri | 63017 | — |
| Investigational Site Number 840502 | Butte | Montana | 59701 | — |
| Investigational Site Number 840084 | Fremont | Nebraska | 68025 | — |
| Investigational Site Number 840085 | Omaha | Nebraska | 68130 | — |
| Investigational Site Number 840162 | Las Vegas | Nevada | 89102 | — |
| Investigational Site Number 840527 | Las Vegas | Nevada | 89117 | — |
| Investigational Site Number 840056 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840135 | Summit | New Jersey | 07901 | — |
| Investigational Site Number 840145 | Toms River | New Jersey | 08721 | — |
| Investigational Site Number 840087 | Toms River | New Jersey | 08753 | — |
| Investigational Site Number 840140 | Calabash | North Carolina | 28467 | — |
| Investigational Site Number 840139 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 840153 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 840047 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840024 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 840065 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840007 | Cincinnati | Ohio | 45236 | — |
| Investigational Site Number 840097 | Columbus | Ohio | 43213 | — |
| Investigational Site Number 840113 | Dayton | Ohio | 45439 | — |
| Investigational Site Number 840108 | Maumee | Ohio | 43537 | — |
| Investigational Site Number 840504 | Eugene | Oregon | — | — |
| Investigational Site Number 840080 | Medford | Oregon | 97504 | — |
| Investigational Site Number 840148 | Tipton | Pennsylvania | 16684 | — |
| Investigational Site Number 840005 | Uniontown | Pennsylvania | 15401 | — |
| Investigational Site Number 840076 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840503 | Simpsonville | South Carolina | 29681 | — |
| Investigational Site Number 840048 | Rapid City | South Dakota | 57701 | — |
| Investigational Site Number 840028 | Bristol | Tennessee | 37620 | — |
| Investigational Site Number 840038 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840042 | Knoxville | Tennessee | 37912 | — |
| Investigational Site Number 840160 | Memphis | Tennessee | 38119 | — |
| Investigational Site Number 840033 | Memphis | Tennessee | 38125 | — |
| Investigational Site Number 840022 | Austin | Texas | 78731 | — |
| Investigational Site Number 840078 | Austin | Texas | 78758 | — |
| Investigational Site Number 840519 | Corpus Christi | Texas | 78404 | — |
| Investigational Site Number 840001 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840159 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840115 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840079 | Houston | Texas | 77030 | — |
| Investigational Site Number 840514 | Houston | Texas | 77074 | — |
| Investigational Site Number 840525 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840161 | San Antonio | Texas | 78258 | — |
| Investigational Site Number 840009 | Draper | Utah | 84020 | — |
| Investigational Site Number 840037 | Orem | Utah | 84058 | — |
| Investigational Site Number 840510 | Salt Lake City | Utah | 84107 | — |
| Investigational Site Number 840032 | Chesapeake | Virginia | 23321 | — |
| Investigational Site Number 840040 | Norfolk | Virginia | 23510 | — |
| Investigational Site Number 840095 | Richmond | Virginia | 23235 | — |
| Investigational Site Number 840072 | Williamsburg | Virginia | 23185 | — |
| Investigational Site Number 840134 | Winchester | Virginia | 22601 | — |
| Investigational Site Number 840523 | Olympia | Washington | 98502 | — |
| Investigational Site Number 840122 | Walla Walla | Washington | 99362 | — |
| Investigational Site Number 840019 | 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 103 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01499095, 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 22, 2022 · Synced Sep 1, 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 protocol, eligibility criteria, and contact information for NCT01499095 live on ClinicalTrials.gov.