A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Public ClinicalTrials.gov record NCT02531035. 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 Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Study identification
- NCT ID
- NCT02531035
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,405 participants
Conditions and interventions
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 2015 (Actual)
- Primary completion
- Apr 2017 (Actual)
- Completion
- Apr 2017 (Actual)
- Last update posted
- Feb 12, 2020
2015 – 2017
United States locations
- U.S. sites
- 33
- U.S. states
- 19
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lexicon Investigational Site | Concord | California | 94520 | — |
| Lexicon Investigational Site | Escondido | California | 92025 | — |
| Lexicon Investigational Site | La Jolla | California | 92037 | — |
| Lexicon Investigational Site | San Marcos | California | 94401 | — |
| Lexicon Investigational Site | Ventura | California | 93003 | — |
| Lexicon Investigational Site | Walnut Creek | California | 94598 | — |
| Lexicon Investigational Site | Aurora | Colorado | 80045 | — |
| Lexicon Investigational Site | New Haven | Connecticut | 06511 | — |
| Lexicon Investigational Site | Orlando | Florida | 32804 | — |
| Lexicon Investigational Site | West Palm Beach | Florida | 33401 | — |
| Lexicon Investigational Site | Atlanta | Georgia | 30318 | — |
| Lexicon Investigational Site | Macon | Georgia | 31210 | — |
| Lexicon Investigational Site | Roswell | Georgia | 30076 | — |
| Lexicon Investigational Site | New Orleans | Louisiana | 70112 | — |
| Lexicon Investigational Site | Rockville | Maryland | 20852 | — |
| Lexicon Investigational Site | Boston | Massachusetts | 02215 | — |
| Lexicon Investigational Site | Bloomfield Hills | Michigan | 48302 | — |
| Lexicon Investigational Site | Omaha | Nebraska | 68114 | — |
| Lexicon Investigational Site | Las Vegas | Nevada | 89148 | — |
| Lexicon Investigational Site | Albany | New York | 12206 | — |
| Lexicon Investigational Site | The Bronx | New York | 10467 | — |
| Lexicon Investigational Site | Asheville | North Carolina | 28803 | — |
| Lexicon Investigational Site | Chapel Hill | North Carolina | 27517 | — |
| Lexicon Investigational Site | Greenville | North Carolina | 27834 | — |
| Lexicon Investigational Site | Morehead City | North Carolina | 28557 | — |
| Lexicon Investigational Site | Grand Forks | North Dakota | 58201 | — |
| Lexicon Investigational Site | Bend | Oregon | 97701 | — |
| Lexicon Investigational Site | Sioux Falls | South Dakota | 57104 | — |
| Lexicon Investigational Site | Austin | Texas | 78731 | — |
| Lexicon Investigational Site | San Antonio | Texas | 78229 | — |
| Lexicon Investigational Site | Shavano Park | Texas | 78231 | — |
| Lexicon Investigational Site | Salt Lake City | Utah | 84107 | — |
| 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 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02531035, 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 NCT02531035 live on ClinicalTrials.gov.