ClinicalTrials.gov record
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
ClinicalTrials.gov ID: NCT01676220
Public ClinicalTrials.gov record NCT01676220. 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® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs 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 a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: \- occurrence of nocturnal hypoglycemia
Study identification
- NCT ID
- NCT01676220
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 878 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
- Aug 2012 (Type not available)
- Primary completion
- Sep 2013 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Jun 24, 2015
2012 – 2014
United States locations
- U.S. sites
- 117
- U.S. states
- 36
- U.S. cities
- 96
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840324 | Montgomery | Alabama | 36109 | — |
| Investigational Site Number 840273 | Chandler | Arizona | 85224 | — |
| Investigational Site Number 840217 | Mesa | Arizona | 85206 | — |
| Investigational Site Number 840220 | Peoria | Arizona | 85050 | — |
| Investigational Site Number 840211 | Phoenix | Arizona | 85028 | — |
| Investigational Site Number 840207 | Phoenix | Arizona | 85050 | — |
| Investigational Site Number 840264 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840234 | Tempe | Arizona | — | — |
| Investigational Site Number 840304 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840347 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840244 | Escondido | California | 92025 | — |
| Investigational Site Number 840257 | Fresno | California | 93720 | — |
| Investigational Site Number 840213 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840267 | Huntington Beach | California | 92648 | — |
| Investigational Site Number 840230 | La Jolla | California | 92037 | — |
| Investigational Site Number 840235 | La Mesa | California | 91942 | — |
| Investigational Site Number 840274 | La Mesa | California | 91942 | — |
| Investigational Site Number 840222 | Long Beach | California | 90806 | — |
| Investigational Site Number 840243 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840250 | Spring Valley | California | 91978 | — |
| Investigational Site Number 840209 | Temecula | California | 92591 | — |
| Investigational Site Number 840297 | Torrance | California | 90502 | — |
| Investigational Site Number 840272 | Tustin | California | 92780 | — |
| Investigational Site Number 840223 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 840249 | Colorado Springs | Colorado | 80907 | — |
| Investigational Site Number 840331 | Denver | Colorado | 80212 | — |
| Investigational Site Number 840299 | Boca Raton | Florida | 33432 | — |
| Investigational Site Number 840285 | Boynton Beach | Florida | 33472 | — |
| Investigational Site Number 840221 | Bradenton | Florida | 34208 | — |
| Investigational Site Number 840233 | Clearwater | Florida | 33765 | — |
| Investigational Site Number 840212 | Coral Gables | Florida | 33134 | — |
| Investigational Site Number 840266 | Coral Gables | Florida | 33134 | — |
| Investigational Site Number 840204 | Hialeah | Florida | 33012 | — |
| Investigational Site Number 840248 | Hollywood | Florida | 33021 | — |
| Investigational Site Number 840226 | Jacksonville | Florida | 32205 | — |
| Investigational Site Number 840318 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840224 | Jacksonville | Florida | 32258 | — |
| Investigational Site Number 840228 | Miami | Florida | 33144 | — |
| Investigational Site Number 840238 | Miami | Florida | 33144 | — |
| Investigational Site Number 840302 | Miami | Florida | 33176 | — |
| Investigational Site Number 840337 | Miami Beach | Florida | 33141 | — |
| Investigational Site Number 840227 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840303 | North Miami Beach | Florida | 33162 | — |
| Investigational Site Number 840225 | Ocala | Florida | 34471 | — |
| Investigational Site Number 840291 | Orlando | Florida | 32804 | — |
| Investigational Site Number 840316 | Orlando | Florida | 32806 | — |
| Investigational Site Number 840216 | Oviedo | Florida | 32765 | — |
| Investigational Site Number 840332 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840288 | Pembroke Pines | Florida | 33028 | — |
| Investigational Site Number 840325 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 840309 | St. Petersburg | Florida | 33716 | — |
| Investigational Site Number 840251 | Tampa | Florida | 33603 | — |
| Investigational Site Number 840339 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 840245 | Atlanta | Georgia | 30308 | — |
| Investigational Site Number 840323 | Stockbridge | Georgia | 30281 | — |
| Investigational Site Number 840236 | Honolulu | Hawaii | 96814 | — |
| Investigational Site Number 840283 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840278 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 840320 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840276 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840314 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840317 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840214 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840232 | Overland Park | Kansas | 66210 | — |
| Investigational Site Number 840287 | Topeka | Kansas | 66606 | — |
| Investigational Site Number 840344 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 840231 | Murray | Kentucky | 42003 | — |
| Investigational Site Number 840348 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840290 | New Orleans | Louisiana | 70119 | — |
| Investigational Site Number 840208 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840301 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840289 | Fall River | Massachusetts | 02720 | — |
| Investigational Site Number 840253 | Haverhill | Massachusetts | 1830 | — |
| Investigational Site Number 840270 | Madison Heights | Michigan | 48071 | — |
| Investigational Site Number 840300 | Omaha | Nebraska | 68105 | — |
| Investigational Site Number 840210 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840263 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840349 | Las Vegas | Nevada | 89117 | — |
| Investigational Site Number 840201 | Las Vegas | Nevada | 89119 | — |
| Investigational Site Number 840256 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840306 | Hamilton | New Jersey | 08619 | — |
| Investigational Site Number 840203 | Sea Girt | New Jersey | 08750 | — |
| Investigational Site Number 840295 | Sicklerville | New Jersey | 08081 | — |
| Investigational Site Number 840269 | Albuquerque | New Mexico | 87106 | — |
| Investigational Site Number 840310 | New Hyde Park | New York | 11042 | — |
| Investigational Site Number 840247 | Asheville | North Carolina | 28803 | — |
| Investigational Site Number 840296 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 840275 | Morganton | North Carolina | 28655 | — |
| Investigational Site Number 840330 | Cleveland | Ohio | 44122 | — |
| Investigational Site Number 840307 | Columbus | Ohio | 43213 | — |
| Investigational Site Number 840229 | Norman | Oklahoma | 73069 | — |
| Investigational Site Number 840219 | Bend | Oregon | 97701 | — |
| Investigational Site Number 840240 | Philadelphia | Pennsylvania | 19139 | — |
| Investigational Site Number 840308 | Tipton | Pennsylvania | 16684 | — |
| Investigational Site Number 840252 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840237 | Spartanburg | South Carolina | 29303 | — |
| Investigational Site Number 840294 | Dakota Dunes | South Dakota | 57049 | — |
| Investigational Site Number 840260 | Bristol | Tennessee | 37620 | — |
| Investigational Site Number 840262 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840342 | Corpus Christi | Texas | 78404 | — |
| Investigational Site Number 840268 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840292 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840315 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840242 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840326 | Edinburg | Texas | 78539 | — |
| Investigational Site Number 840338 | Houston | Texas | 77002 | — |
| Investigational Site Number 840218 | Houston | Texas | 77004 | — |
| Investigational Site Number 840328 | Houston | Texas | 77074 | — |
| Investigational Site Number 840259 | Houston | Texas | 77095 | — |
| Investigational Site Number 840327 | Pearland | Texas | 77584 | — |
| Investigational Site Number 840282 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840202 | Murray | Utah | 84123 | — |
| Investigational Site Number 840343 | Salt Lake City | Utah | 84107 | — |
| Investigational Site Number 840239 | Burke | Virginia | 22015 | — |
| Investigational Site Number 840206 | Manassas | Virginia | 20110 | — |
| Investigational Site Number 840246 | Renton | Washington | 98055 | — |
| Investigational Site Number 840311 | 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 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01676220, 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 Jun 24, 2015 · 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 NCT01676220 live on ClinicalTrials.gov.