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Completed Phase 3 Interventional Results available

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.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 11:24 PM EDT

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

Study identification

NCT ID
NCT01676220
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
878 participants

Conditions and interventions

Interventions

  • HOE901-U300 (new formulation of insulin glargine) Drug
  • Lantus (insulin glargine) 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
Jul 31, 2012
Primary completion
Aug 31, 2013
Completion
Feb 28, 2014
Last update posted
Jun 23, 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 23, 2015 · Synced Jun 26, 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 NCT01676220 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →