Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT01683266. 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 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 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 a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: * To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: * Change of HbA1c from baseline to endpoint (scheduled Month 6) * Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) * Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) * Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) * Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
Study identification
- NCT ID
- NCT01683266
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 549 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
- Sep 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
- 82
- U.S. states
- 36
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840156 | Chandler | Arizona | 85224 | — |
| Investigational Site Number 840177 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840430 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840131 | Escondido | California | 92025 | — |
| Investigational Site Number 840140 | Fresno | California | 93720 | — |
| Investigational Site Number 840107 | Greenbrae | California | 94904 | — |
| Investigational Site Number 840149 | Huntington Beach | California | 92648 | — |
| Investigational Site Number 840120 | La Jolla | California | 92037 | — |
| Investigational Site Number 840123 | La Mesa | California | 91942 | — |
| Investigational Site Number 840159 | La Mesa | California | 91942 | — |
| Investigational Site Number 840114 | Long Beach | California | 90806 | — |
| Investigational Site Number 840189 | Mission Hills | California | 91345 | — |
| Investigational Site Number 840105 | Temecula | California | 92591 | — |
| Investigational Site Number 840155 | Tustin | California | 92780 | — |
| Investigational Site Number 840115 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 840160 | Denver | Colorado | 80239 | — |
| Investigational Site Number 840188 | Denver | Colorado | 80262 | — |
| Investigational Site Number 840196 | New Haven | Connecticut | 06520 | — |
| Investigational Site Number 840113 | Bradenton | Florida | 34208 | — |
| Investigational Site Number 840102 | Hialeah | Florida | 33012 | — |
| Investigational Site Number 840134 | Hollywood | Florida | 33021 | — |
| Investigational Site Number 840185 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840116 | Jacksonville | Florida | 32258 | — |
| Investigational Site Number 840126 | Miami | Florida | 33144 | — |
| Investigational Site Number 840179 | Miami | Florida | 33176 | — |
| Investigational Site Number 840117 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840174 | Orlando | Florida | 32806 | — |
| Investigational Site Number 840110 | Oviedo | Florida | 32765 | — |
| Investigational Site Number 840178 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840181 | Tampa | Florida | 33613 | — |
| Investigational Site Number 840420 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 840195 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 840124 | Honolulu | Hawaii | 96814 | — |
| Investigational Site Number 840167 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840163 | Nampa | Idaho | 83686 | — |
| Investigational Site Number 840162 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840172 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840197 | Indianapolis | Indiana | 46202 | — |
| Investigational Site Number 840108 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840407 | Iowa City | Iowa | — | — |
| Investigational Site Number 840170 | Topeka | Kansas | 66606 | — |
| Investigational Site Number 840421 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 840426 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840104 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840180 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840137 | Haverhill | Massachusetts | 1830 | — |
| Investigational Site Number 840408 | Detroit | Michigan | 48202 | — |
| Investigational Site Number 840153 | Madison Heights | Michigan | 48071 | — |
| Investigational Site Number 840171 | Saint Louis Park | Minnesota | 55416 | — |
| Investigational Site Number 840184 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840106 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840145 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840139 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840151 | Albuquerque | New Mexico | 87106 | — |
| Investigational Site Number 840191 | New Hyde Park | New York | 11042 | — |
| Investigational Site Number 840173 | Syracuse | New York | 13210 | — |
| Investigational Site Number 840133 | Asheville | North Carolina | 28803 | — |
| Investigational Site Number 840175 | Chapel Hill | North Carolina | 27599-7295 | — |
| Investigational Site Number 840161 | Morganton | North Carolina | 28655 | — |
| Investigational Site Number 840169 | Mentor | Ohio | 44060 | — |
| Investigational Site Number 840119 | Norman | Oklahoma | 73069 | — |
| Investigational Site Number 840112 | Bend | Oregon | 97701 | — |
| Investigational Site Number 840136 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840122 | Dakota Dunes | South Dakota | 57049 | — |
| Investigational Site Number 840144 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840187 | Nashville | Tennessee | 37232 | — |
| Investigational Site Number 840109 | Austin | Texas | 78731 | — |
| Investigational Site Number 840157 | Austin | Texas | 78731 | — |
| Investigational Site Number 840150 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840412 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840130 | Houston | Texas | 77030 | — |
| Investigational Site Number 840141 | Houston | Texas | 77095 | — |
| Investigational Site Number 840166 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840101 | Murray | Utah | 84123 | — |
| Investigational Site Number 840125 | Burke | Virginia | 22015 | — |
| Investigational Site Number 840427 | Chesapeake | Virginia | 23321 | — |
| Investigational Site Number 840103 | Manassas | Virginia | 20110 | — |
| Investigational Site Number 840132 | Renton | Washington | 98055 | — |
| Investigational Site Number 840403 | Seattle | Washington | 98195 | — |
| Investigational Site Number 840402 | Spokane | Washington | 99220 | — |
| Investigational Site Number 840127 | Tacoma | Washington | 98415-0299 | — |
| Investigational Site Number 840411 | 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 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01683266, 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 17, 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 NCT01683266 live on ClinicalTrials.gov.