Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy
Public ClinicalTrials.gov record NCT02926937. 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 as Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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 in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise. Secondary Objectives: * To compare Sotagliflozin 400 mg versus placebo based on: * 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 per mercury (mmHg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Proportion of participants with HbA1c \<6.5%, \<7.0%. * To compare Sotagliflozin 200 mg versus placebo based on: * Change from baseline in HbA1c. * Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. * Change from baseline in body weight. * Change from baseline in SBP for all participants. * To evaluate the safety of Sotagliflozin 400 and 200 mg versus placebo.
Study identification
- NCT ID
- NCT02926937
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 399 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 10, 2016
- Primary completion
- Apr 21, 2019
- Completion
- May 16, 2019
- Last update posted
- Jun 20, 2021
2016 – 2019
United States locations
- U.S. sites
- 56
- U.S. states
- 16
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8401049 | Tucson | Arizona | 85741 | — |
| Investigational Site Number 8401026 | Tucson | Arizona | 85745 | — |
| Investigational Site Number 8401028 | Anaheim | California | 92801 | — |
| Investigational Site Number 8401057 | Canoga Park | California | 91303 | — |
| Investigational Site Number 8401058 | Garden Grove | California | 92844-2751 | — |
| Investigational Site Number 8401029 | Hawaiian Gardens | California | 90716 | — |
| Investigational Site Number 8401017 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8401056 | Long Beach | California | 90806 | — |
| Investigational Site Number 8401013 | Long Beach | California | 90807 | — |
| Investigational Site Number 8401063 | Los Angeles | California | 90036 | — |
| Investigational Site Number 8401011 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8401022 | Montclair | California | 91763 | — |
| Investigational Site Number 8401039 | Norwalk | California | 90650 | — |
| Investigational Site Number 8401035 | San Dimas | California | 91713 | — |
| Investigational Site Number 8401025 | Tustin | California | 92780 | — |
| Investigational Site Number 8401015 | Van Nuys | California | 91405 | — |
| Investigational Site Number 8401031 | Denver | Colorado | 80220 | — |
| Investigational Site Number 8401060 | Northglenn | Colorado | 80234 | — |
| Investigational Site Number 8401024 | Bradenton | Florida | 34201 | — |
| Investigational Site Number 8401040 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 8401014 | Daytona Beach | Florida | 32117 | — |
| Investigational Site Number 8401007 | Hialeah | Florida | 33012 | — |
| Investigational Site Number 8401046 | Homestead | Florida | 33030 | — |
| Investigational Site Number 8401018 | Miami | Florida | 33135 | — |
| Investigational Site Number 8401008 | Miami | Florida | 33185 | — |
| Investigational Site Number 8401053 | Orlando | Florida | 32825 | — |
| Investigational Site Number 8401062 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 8401061 | West Palm Beach | Florida | 33406-5854 | — |
| Investigational Site Number 8401033 | Atlanta | Georgia | 30303 | — |
| Investigational Site Number 8401044 | Chicago | Illinois | 60602 | — |
| Investigational Site Number 8401052 | Newton | Iowa | 50208 | — |
| Investigational Site Number 8401016 | West Des Moines | Iowa | 50265 | — |
| Investigational Site Number 8401034 | Wichita | Kansas | 67205-1138 | — |
| Investigational Site Number 8401038 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 8401042 | Fayetteville | North Carolina | 28314 | — |
| Investigational Site Number 8401012 | Greensboro | North Carolina | 27401 | — |
| Investigational Site Number 8401048 | Akron | Ohio | 44311 | — |
| Investigational Site Number 8401003 | Marion | Ohio | 43302 | — |
| Investigational Site Number 8401020 | Corvallis | Oregon | 97330 | — |
| Investigational Site Number 8401006 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 8401041 | Levittown | Pennsylvania | 19056 | — |
| Investigational Site Number 8401051 | Anderson | South Carolina | 29621 | — |
| Investigational Site Number 8401002 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 8401005 | Fort Worth | Texas | 76164 | — |
| Investigational Site Number 8401019 | Houston | Texas | 77081 | — |
| Investigational Site Number 8401050 | Houston | Texas | 77099 | — |
| Investigational Site Number 8401037 | Katy | Texas | 77450 | — |
| Investigational Site Number 8401043 | McAllen | Texas | 78504 | — |
| Investigational Site Number 8401059 | North Richland Hills | Texas | 76180 | — |
| Investigational Site Number 8401004 | San Antonio | Texas | 78218 | — |
| Investigational Site Number 8401054 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 8401001 | San Antonio | Texas | 78231 | — |
| Investigational Site Number 8401055 | Schertz | Texas | 78154 | — |
| Investigational Site Number 8401023 | Sugar Land | Texas | 77478 | — |
| Investigational Site Number 8401032 | Chesapeake | Virginia | 23321-5205 | — |
| Investigational Site Number 8401010 | Suffolk | Virginia | 23435-3763 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02926937, 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 Jun 20, 2021 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02926937 live on ClinicalTrials.gov.