Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
Public ClinicalTrials.gov record NCT03351478. 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.
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Official title
A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is 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 on a DPP4(i) with or without metformin.
Study identification
- NCT ID
- NCT03351478
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 770 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 27, 2017 (Actual)
- Primary completion
- May 16, 2019 (Actual)
- Completion
- May 16, 2019 (Actual)
- Last update posted
- May 11, 2021
2017 – 2019
United States locations
- U.S. sites
- 53
- U.S. states
- 20
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8408035 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 8408028 | Sheffield | Alabama | 35660 | — |
| Investigational Site Number 8408047 | Hawaiian Gardens | California | 90716 | — |
| Investigational Site Number 8408031 | Spring Valley | California | 91978 | — |
| Investigational Site Number 8408067 | Van Nuys | California | 91405 | — |
| Investigational Site Number 8408069 | Northglenn | Colorado | 80234 | — |
| Investigational Site Number 8408009 | Miami | Florida | 33183-4825 | — |
| Investigational Site Number 8408049 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8408005 | Orlando | Florida | 32810 | — |
| Investigational Site Number 8408040 | Orlando | Florida | 32825 | — |
| Investigational Site Number 8408019 | Palmetto Bay | Florida | 33157-5503 | — |
| Investigational Site Number 8408064 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 8408061 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 8408074 | Macon | Georgia | 31210 | — |
| Investigational Site Number 8408079 | Savannah | Georgia | 31406 | — |
| Investigational Site Number 8408059 | Statesboro | Georgia | 30461-0845 | — |
| Investigational Site Number 8408051 | Blackfoot | Idaho | 83221 | — |
| Investigational Site Number 8408033 | Elgin | Illinois | 60124 | — |
| Investigational Site Number 8408003 | New Orleans | Louisiana | 70124 | — |
| Investigational Site Number 8408002 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 8408044 | Fall River | Massachusetts | 02721-3005 | — |
| Investigational Site Number 8408008 | Flint | Michigan | 48532 | — |
| Investigational Site Number 8408027 | West Seneca | New York | 14224 | — |
| Investigational Site Number 8408037 | Fayetteville | North Carolina | 28314 | — |
| Investigational Site Number 8408053 | Greensboro | North Carolina | 27408-7042 | — |
| Investigational Site Number 8408012 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 8408013 | Salisbury | North Carolina | 28144-2742 | — |
| Investigational Site Number 8408045 | Oklahoma City | Oklahoma | 73104-3252 | — |
| Investigational Site Number 8408068 | Warwick | Rhode Island | 02888-3360 | — |
| Investigational Site Number 8408060 | Fort Mill | South Carolina | 29707-4514 | — |
| Investigational Site Number 8408018 | Jefferson City | Tennessee | 37760 | — |
| Investigational Site Number 8408010 | Knoxville | Tennessee | 37912-4707 | — |
| Investigational Site Number 8408038 | Knoxville | Tennessee | 37938 | — |
| Investigational Site Number 8408072 | Brownsville | Texas | 78520-7512 | — |
| Investigational Site Number 8408056 | Dallas | Texas | 75208 | — |
| Investigational Site Number 8408082 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8408052 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8408001 | Houston | Texas | 77004 | — |
| Investigational Site Number 8408032 | Houston | Texas | 77004 | — |
| Investigational Site Number 8408016 | Houston | Texas | 77040 | — |
| Investigational Site Number 8408017 | Houston | Texas | 77058 | — |
| Investigational Site Number 8408036 | Houston | Texas | 77061 | — |
| Investigational Site Number 8408022 | Houston | Texas | 77099 | — |
| Investigational Site Number 8408029 | Katy | Texas | 77450 | — |
| Investigational Site Number 8408054 | McAllen | Texas | 78504 | — |
| Investigational Site Number 8408039 | Mesquite | Texas | 75149 | — |
| Investigational Site Number 8408042 | Plano | Texas | 75024 | — |
| Investigational Site Number 8408011 | San Antonio | Texas | 78229-3818 | — |
| Investigational Site Number 8408041 | Schertz | Texas | 78154 | — |
| Investigational Site Number 8408007 | Bountiful | Utah | 84010-7717 | — |
| Investigational Site Number 8408026 | Holladay | Utah | 84117 | — |
| Investigational Site Number 8408006 | Burke | Virginia | 22015 | — |
| Investigational Site Number 8408004 | Manassas | Virginia | 20110 | — |
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 107 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03351478, 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 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03351478 live on ClinicalTrials.gov.