Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Public ClinicalTrials.gov record NCT03066830. 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 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: * To compare Sotagliflozin 400 mg versus placebo based on: * 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 (mm Hg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Percentage of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.
Study identification
- NCT ID
- NCT03066830
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 507 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
- Feb 23, 2017
- Primary completion
- Apr 16, 2019
- Completion
- Apr 29, 2019
- Last update posted
- May 10, 2021
2017 – 2019
United States locations
- U.S. sites
- 28
- U.S. states
- 13
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8403003 | Litchfield Park | Arizona | 85340 | — |
| Investigational Site Number 8403018 | Peoria | Arizona | 85381 | — |
| Investigational Site Number 8403009 | Greenbrae | California | 94904 | — |
| Investigational Site Number 8403012 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8403019 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8403034 | Montclair | California | 91763 | — |
| Investigational Site Number 8403016 | Spring Valley | California | 91978 | — |
| Investigational Site Number 8403014 | Tustin | California | 92780 | — |
| Investigational Site Number 8403001 | Northglenn | Colorado | 80234 | — |
| Investigational Site Number 8403029 | Bradenton | Florida | 34201 | — |
| Investigational Site Number 8403004 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 8403020 | North Miami Beach | Florida | 33162 | — |
| Investigational Site Number 8403026 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8403032 | Orlando | Florida | 32810 | — |
| Investigational Site Number 8403008 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 8403006 | Pembroke Pines | Florida | 33026 | — |
| Investigational Site Number 8403013 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 8403007 | Nampa | Idaho | 83686 | — |
| Investigational Site Number 8403011 | Flint | Michigan | 48532 | — |
| Investigational Site Number 8403025 | Richfield | Minnesota | 55432 | — |
| Investigational Site Number 8403021 | Henderson | Nevada | 89014 | — |
| Investigational Site Number 8403028 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 8403015 | Shelby | North Carolina | 28150 | — |
| Investigational Site Number 8403033 | Hatboro | Pennsylvania | 19040 | — |
| Investigational Site Number 8403030 | Kingsport | Tennessee | 37660 | — |
| Investigational Site Number 8403002 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8403022 | Houston | Texas | 77081 | — |
| Investigational Site Number 8403005 | Burke | Virginia | 22015 | — |
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 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03066830, 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 10, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03066830 live on ClinicalTrials.gov.