Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Public ClinicalTrials.gov record NCT02384941. 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 Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
Study identification
- NCT ID
- NCT02384941
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 793 participants
Conditions and interventions
Conditions
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
- Mar 2015 (Actual)
- Primary completion
- Sep 2016 (Actual)
- Completion
- Feb 2017 (Actual)
- Last update posted
- Feb 12, 2020
2015 – 2017
United States locations
- U.S. sites
- 63
- U.S. states
- 28
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lexicon Investigational Site | Birmingham | Alabama | 35294 | — |
| Lexicon Investigational Site | Little Rock | Arkansas | 72205 | — |
| Lexicon Investigational Site | Escondido | California | 92025 | — |
| Lexicon Investigational Site | Greenbrae | California | 94904 | — |
| Lexicon Investigational Site | Huntington Beach | California | 92648 | — |
| Lexicon Investigational Site | La Jolla | California | 92037 | — |
| Lexicon Investigational Site | Los Angeles | California | 90057-3550 | — |
| Lexicon Investigational Site | Orange | California | 92868 | — |
| Lexicon Investigational Site | Palm Springs | California | 92262 | — |
| Lexicon Investigational Site | San Mateo | California | 94401 | — |
| Lexicon Investigational Site | Tarzana | California | 91356 | — |
| Lexicon Investigational Site | Tustin | California | 92780 | — |
| Lexicon Investigational Site | Walnut Creek | California | 94598 | — |
| Lexicon Investigational Site | Aurora | Colorado | 70045 | — |
| Lexicon Investigational Site | Longmont | Colorado | 80501 | — |
| Lexicon Investigational Site | Fleming Island | Florida | 32003 | — |
| Lexicon Investigational Site | Jacksonville | Florida | 32204 | — |
| Lexicon Investigational Site | Jacksonville | Florida | 32216 | — |
| Lexicon Investigational Site | New Port Richey | Florida | 34652 | — |
| Lexicon Investigational Site | Ormond Beach | Florida | 32174 | — |
| Lexicon Investigational Site | West Palm Beach | Florida | 33401 | — |
| Lexicon Investigational Site | Atlanta | Georgia | 30318 | — |
| Lexicon Investigational Site | Lawrenceville | Georgia | 30046 | — |
| Lexicon Investigational Site | Roswell | Georgia | 30076 | — |
| Lexicon Investigational Site | Honolulu | Hawaii | 96814 | — |
| Lexicon Investigational Site | Crystal Lake | Illinois | 60012 | — |
| Lexicon Investigational Site | Elgin | Illinois | 60123 | — |
| Lexicon Investigational Site | Springfield | Illinois | 62711 | — |
| Lexicon Investigational Site | Topeka | Kansas | 66606 | — |
| Lexicon Investigational Site | Lexington | Kentucky | 40503 | — |
| Lexicon Investigational Site | Bangor | Maine | 04401 | — |
| Lexicon Investigational Site | Baltimore | Maryland | 21204 | — |
| Lexicon Investigational Site | Boston | Massachusetts | 02215 | — |
| Lexicon Investigational Site | Detroit | Michigan | 46214 | — |
| Lexicon Investigational Site | Chesterfield | Missouri | 63017 | — |
| Lexicon Investigational Site | St Louis | Missouri | 63110 | — |
| Lexicon Investigational Site | Omaha | Nebraska | 68131 | — |
| Lexicon Investigational Site | Henderson | Nevada | 89052 | — |
| Lexicon Investigational Site | Las Vegas | Nevada | 89148 | — |
| Lexicon Investigational Site | Albany | New York | 12206 | — |
| Lexicon Investigational Site | New York | New York | 10029 | — |
| Lexicon Investigational Site | Asheville | North Carolina | 28803 | — |
| Lexicon Investigational Site | Chapel Hill | North Carolina | 27517 | — |
| Lexicon Investigational Site | Morehead City | North Carolina | 28557 | — |
| Lexicon Investigational Site | Columbus | Ohio | 43201 | — |
| Lexicon Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| Lexicon Investigational Site | Portland | Oregon | 97239 | — |
| Lexicon Investigational Site | Greer | South Carolina | 29651 | — |
| Lexicon Investigational Site | Rapid City | South Dakota | 57701 | — |
| Lexicon Investigational Site | Chattanooga | Tennessee | 37404 | — |
| Lexicon Investigational Site | Chattanooga | Tennessee | 37411 | — |
| Lexicon Investigational Site | Memphis | Tennessee | 38119 | — |
| Lexicon Investigational Site | Austin | Texas | 78749 | — |
| Lexicon Investigational Site | Dallas | Texas | 75230 | — |
| Lexicon Investigational Site | Dallas | Texas | 75231 | — |
| Lexicon Investigational Site | Dallas | Texas | 75246 | — |
| Lexicon Investigational Site | Houston | Texas | 77079 | — |
| Lexicon Investigational Site | Houston | Texas | 77095 | — |
| Lexicon Investigational Site | San Antonio | Texas | 78258 | — |
| Lexicon Investigational Site | Schertz | Texas | 78154 | — |
| Lexicon Investigational Site | Chesapeake | Virginia | 23321 | — |
| Lexicon Investigational Site | Renton | Washington | 98057 | — |
| Lexicon Investigational Site | Seattle | Washington | 98105 | — |
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 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02384941, 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 Feb 12, 2020 · Synced Oct 27, 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 NCT02384941 live on ClinicalTrials.gov.