Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
Public ClinicalTrials.gov record NCT03434119. 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 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: * To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population. * To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians). Secondary Objective: * To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated. * To assess the change in daily insulin glargine dose within each ethnic/racial subgroup. * To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.
Study identification
- NCT ID
- NCT03434119
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 241 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
- Feb 19, 2018
- Primary completion
- Jan 6, 2019
- Completion
- Jan 6, 2019
- Last update posted
- Mar 27, 2022
2018 – 2019
United States locations
- U.S. sites
- 85
- U.S. states
- 19
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400072 | Montgomery | Alabama | 36106 | — |
| Investigational Site Number 8400077 | Little Rock | Arkansas | 72204 | — |
| Investigational Site Number 8400095 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 8400013 | Little Rock | Arkansas | 72211 | — |
| Investigational Site Number 8400076 | Anaheim | California | 92801-4123 | — |
| Investigational Site Number 8400052 | Anaheim | California | 92801 | — |
| Investigational Site Number 8400069 | Anaheim | California | 92805 | — |
| Investigational Site Number 8400060 | Burbank | California | 91505 | — |
| Investigational Site Number 8400049 | Cerritos | California | 90703 | — |
| Investigational Site Number 8400078 | Chula Vista | California | 91910 | — |
| Investigational Site Number 8400047 | Escondido | California | 92025 | — |
| Investigational Site Number 8400066 | Fountain Valley | California | 92708 | — |
| Investigational Site Number 8400050 | Greenbrae | California | 94904 | — |
| Investigational Site Number 8400092 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8400015 | Los Angeles | California | 90017 | — |
| Investigational Site Number 8400011 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8400301 | Los Angeles | California | 90094 | — |
| Investigational Site Number 8400302 | Los Angeles | California | 90094 | — |
| Investigational Site Number 8400303 | Los Angeles | California | 90094 | — |
| Investigational Site Number 8400304 | Los Angeles | California | 90094 | — |
| Investigational Site Number 8400006 | Los Gatos | California | 95032 | — |
| Investigational Site Number 8400048 | Oakland | California | 94612 | — |
| Investigational Site Number 8400053 | Orange | California | 92868 | — |
| Investigational Site Number 8400084 | Pomona | California | 91766 | — |
| Investigational Site Number 8400081 | Pomona | California | 91767 | — |
| Investigational Site Number 8400042 | Rancho Cucamonga | California | 91730 | — |
| Investigational Site Number 8400063 | San Carlos | California | 94070 | — |
| Investigational Site Number 8400091 | San Diego | California | 92114 | — |
| Investigational Site Number 8400086 | San Jose | California | 95148 | — |
| Investigational Site Number 8400074 | Santa Ana | California | 92701 | — |
| Investigational Site Number 8400037 | Temecula | California | 92591 | — |
| Investigational Site Number 8400087 | Vallejo | California | 94592 | — |
| Investigational Site Number 8400024 | Van Nuys | California | 91405 | — |
| Investigational Site Number 8400007 | Ventura | California | 93003 | — |
| Investigational Site Number 8400054 | Englewood | Colorado | 80113 | — |
| Investigational Site Number 8400023 | Hamden | Connecticut | 06517 | — |
| Investigational Site Number 8400041 | Gainesville | Florida | 32653 | — |
| Investigational Site Number 8400075 | Jacksonville | Florida | 32204 | — |
| Investigational Site Number 8400036 | Miami | Florida | 33144 | — |
| Investigational Site Number 8400017 | Miami | Florida | 33176 | — |
| Investigational Site Number 8400016 | Miami Lakes | Florida | 33014 | — |
| Investigational Site Number 8400014 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8400028 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 8400097 | St. Petersburg | Florida | 00000 | — |
| Investigational Site Number 8400035 | St. Petersburg | Florida | 33713 | — |
| Investigational Site Number 8400094 | Tampa | Florida | 33634 | — |
| Investigational Site Number 8400025 | Atlanta | Georgia | 30303 | — |
| Investigational Site Number 8400051 | Atlanta | Georgia | 30310 | — |
| Investigational Site Number 8400093 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 8400005 | Savannah | Georgia | 31406-2675 | — |
| Investigational Site Number 8400038 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 8400088 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 8400031 | Des Plaines | Illinois | 60018 | — |
| Investigational Site Number 8400064 | Evanston | Illinois | 60201 | — |
| Investigational Site Number 8400057 | Gurnee | Illinois | 60031 | — |
| Investigational Site Number 8400030 | Gretna | Louisiana | 70053 | — |
| Investigational Site Number 8400009 | New Orleans | Louisiana | 70124 | — |
| Investigational Site Number 8400065 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 8400061 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 8400079 | Chelsea | Michigan | 48118 | — |
| Investigational Site Number 8400001 | Flint | Michigan | 48504 | — |
| Investigational Site Number 8400012 | Flint | Michigan | 48532-3447 | — |
| Investigational Site Number 8400090 | Las Vegas | Nevada | 89117 | — |
| Investigational Site Number 8400082 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 8400018 | Linden | New Jersey | 07036 | — |
| Investigational Site Number 8400003 | The Bronx | New York | 10455 | — |
| Investigational Site Number 8400062 | Philadelphia | Pennsylvania | 19107 | — |
| Investigational Site Number 8400043 | Columbia | South Carolina | 29204 | — |
| Investigational Site Number 8400021 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8400040 | Fort Worth | Texas | 76132 | — |
| Investigational Site Number 8400045 | Houston | Texas | 77089 | — |
| Investigational Site Number 8400002 | Humble | Texas | 77338 | — |
| Investigational Site Number 8400039 | Kerrville | Texas | 78028 | — |
| Investigational Site Number 8400096 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 8400027 | San Antonio | Texas | 78228 | — |
| Investigational Site Number 8400083 | San Antonio | Texas | 78230 | — |
| Investigational Site Number 8400008 | Splendora | Texas | 77372 | — |
| Investigational Site Number 8400055 | Spring | Texas | 77379 | — |
| Investigational Site Number 8400070 | Sugar Land | Texas | 77478 | — |
| Investigational Site Number 8400085 | Sugar Land | Texas | 77479 | — |
| Investigational Site Number 8400059 | Webster | Texas | 77598 | — |
| Investigational Site Number 8400044 | Manassas | Virginia | 20110 | — |
| Investigational Site Number 8400068 | Norfolk | Virginia | 23510 | — |
| Investigational Site Number 8400033 | Richmond | Virginia | 23219 | — |
| Investigational Site Number 8400029 | Richland | Washington | 99352 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03434119, 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 27, 2022 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03434119 live on ClinicalTrials.gov.