Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
Public ClinicalTrials.gov record NCT02926950. 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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: * To compare Sotagliflozin versus placebo for. * Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. * Change from baseline in fasting plasma glucose (FPG). * Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mmHg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Proportion of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin versus placebo.
Study identification
- NCT ID
- NCT02926950
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 518 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
- Nov 2016 (Actual)
- Primary completion
- Feb 26, 2019 (Actual)
- Completion
- Mar 22, 2019 (Actual)
- Last update posted
- May 11, 2021
2016 – 2019
United States locations
- U.S. sites
- 67
- U.S. states
- 20
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8402003 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 8402017 | Birmingham | Alabama | 35294 | — |
| Investigational Site Number 8402052 | Phoenix | Arizona | 85018 | — |
| Investigational Site Number 8402056 | Canoga Park | California | 91303 | — |
| Investigational Site Number 8402020 | Escondido | California | 92025 | — |
| Investigational Site Number 8402028 | Gold River | California | 95670 | — |
| Investigational Site Number 8402067 | Greenbrae | California | 94904 | — |
| Investigational Site Number 8402025 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8402051 | La Mirada | California | 90638 | — |
| Investigational Site Number 8402042 | Lemon Grove | California | 91945 | — |
| Investigational Site Number 8402011 | Lincoln | California | 95648 | — |
| Investigational Site Number 8402014 | Long Beach | California | 90807 | — |
| Investigational Site Number 8402066 | Long Beach | California | 90807 | — |
| Investigational Site Number 8402029 | Los Angeles | California | 90022 | — |
| Investigational Site Number 8402041 | Los Angeles | California | 90036 | — |
| Investigational Site Number 8402001 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8402043 | San Diego | California | 92103 | — |
| Investigational Site Number 8402031 | San Ramon | California | 94582 | — |
| Investigational Site Number 8402047 | Tarzana | California | 91356 | — |
| Investigational Site Number 8402009 | Boynton Beach | Florida | 33472 | — |
| Investigational Site Number 8402016 | Daytona Beach | Florida | 32117 | — |
| Investigational Site Number 8402006 | Hialeah | Florida | 33012 | — |
| Investigational Site Number 8402035 | Hialeah | Florida | 33012 | — |
| Investigational Site Number 8402044 | Hialeah | Florida | 33012 | — |
| Investigational Site Number 8402045 | Jacksonville | Florida | 32256 | — |
| Investigational Site Number 8402026 | Miami | Florida | 33126 | — |
| Investigational Site Number 8402036 | Miami | Florida | 33143 | — |
| Investigational Site Number 8402064 | Miami | Florida | 33183 | — |
| Investigational Site Number 8402007 | Miami | Florida | 33185 | — |
| Investigational Site Number 8402061 | Miami | Florida | 33186 | — |
| Investigational Site Number 8402060 | Miami Beach | Florida | 33140-3608 | — |
| Investigational Site Number 8402033 | Opa-locka | Florida | 33054 | — |
| Investigational Site Number 8402039 | Orlando | Florida | 32825 | — |
| Investigational Site Number 8402063 | West Palm Beach | Florida | 33406-5854 | — |
| Investigational Site Number 8402038 | Winter Haven | Florida | 33880 | — |
| Investigational Site Number 8402008 | Macon | Georgia | 31210 | — |
| Investigational Site Number 8402054 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 8402069 | Newton | Iowa | 50208 | — |
| Investigational Site Number 8402022 | West Des Moines | Iowa | 50265 | — |
| Investigational Site Number 8402059 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 8402068 | Baton Rouge | Louisiana | 70808-4124 | — |
| Investigational Site Number 8402012 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 8402037 | New Orleans | Louisiana | 70119-6302 | — |
| Investigational Site Number 8402053 | New Orleans | Louisiana | 70124 | — |
| Investigational Site Number 8402021 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 8402062 | Omaha | Nebraska | 68114-3755 | — |
| Investigational Site Number 8402005 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 8402018 | Greensboro | North Carolina | 27401 | — |
| Investigational Site Number 8402002 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 8402019 | Oklahoma City | Oklahoma | 73104 | — |
| Investigational Site Number 8402015 | Eugene | Oregon | 97404-3233 | — |
| Investigational Site Number 8402058 | Lansdale | Pennsylvania | 19446-1002 | — |
| Investigational Site Number 8402030 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8402050 | DeSoto | Texas | 75115 | — |
| Investigational Site Number 8402010 | Fort Worth | Texas | 76164 | — |
| Investigational Site Number 8402040 | Houston | Texas | 77008 | — |
| Investigational Site Number 8402065 | Houston | Texas | 77058 | — |
| Investigational Site Number 8402057 | Houston | Texas | 77079 | — |
| Investigational Site Number 8402049 | Magnolia | Texas | 77355 | — |
| Investigational Site Number 8402046 | Odessa | Texas | 79761 | — |
| Investigational Site Number 8402013 | San Antonio | Texas | 78218 | — |
| Investigational Site Number 8402004 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 8402023 | Schertz | Texas | 78154 | — |
| Investigational Site Number 8402027 | Clinton | Utah | 84015 | — |
| Investigational Site Number 8402032 | Salt Lake City | Utah | 84107 | — |
| Investigational Site Number 8402024 | Virginia Beach | Virginia | 23454 | — |
| Investigational Site Number 8402034 | 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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02926950, 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 May 11, 2021 · Synced Nov 9, 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 NCT02926950 live on ClinicalTrials.gov.