Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Public ClinicalTrials.gov record NCT03242252. 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, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment 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 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.
Study identification
- NCT ID
- NCT03242252
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 787 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
- Aug 16, 2017 (Actual)
- Primary completion
- Mar 25, 2019 (Actual)
- Completion
- Oct 25, 2019 (Actual)
- Last update posted
- Jun 25, 2021
2017 – 2019
United States locations
- U.S. sites
- 51
- U.S. states
- 20
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8404018 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 8404045 | Guntersville | Alabama | 35976-2206 | — |
| Investigational Site Number 8404004 | Phoenix | Arizona | 85018-2701 | — |
| Investigational Site Number 8404022 | Phoenix | Arizona | 85050-7500 | — |
| Investigational Site Number 8404007 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 8404023 | Chula Vista | California | 91910 | — |
| Investigational Site Number 8404044 | Gold River | California | 95670 | — |
| Investigational Site Number 8404011 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8404003 | Norco | California | 92860 | — |
| Investigational Site Number 8404025 | Northridge | California | 91324 | — |
| Investigational Site Number 8404038 | San Dimas | California | 91713 | — |
| Investigational Site Number 8404019 | Clearwater | Florida | 33761 | — |
| Investigational Site Number 8404001 | DeLand | Florida | 32720-0834 | — |
| Investigational Site Number 8404006 | Ocoee | Florida | 34761-4547 | — |
| Investigational Site Number 8404064 | Orlando | Florida | 32806 | — |
| Investigational Site Number 8404043 | Ormond Beach | Florida | 32174-8187 | — |
| Investigational Site Number 8404013 | Palmetto Bay | Florida | 33157-5503 | — |
| Investigational Site Number 8404016 | Savannah | Georgia | 31406 | — |
| Investigational Site Number 8404040 | Wauconda | Illinois | 60084-2452 | — |
| Investigational Site Number 8404036 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 8404020 | New Orleans | Louisiana | 70119-6302 | — |
| Investigational Site Number 8404014 | Norfolk | Nebraska | 68701 | — |
| Investigational Site Number 8404032 | Papillion | Nebraska | 68046-3136 | — |
| Investigational Site Number 8404048 | Hackensack | New Jersey | 07601-1963 | — |
| Investigational Site Number 8404074 | New York | New York | 00000 | — |
| Investigational Site Number 8404009 | The Bronx | New York | 10455 | — |
| Investigational Site Number 8404051 | Wilmington | North Carolina | 28401-6638 | — |
| Investigational Site Number 8404028 | Winston-Salem | North Carolina | 27103-3914 | — |
| Investigational Site Number 8404029 | Winston-Salem | North Carolina | 27103-4027 | — |
| Investigational Site Number 8404026 | Dayton | Ohio | 45419-4336 | — |
| Investigational Site Number 8404052 | Lansdale | Pennsylvania | 19446-1002 | — |
| Investigational Site Number 8404031 | Anderson | South Carolina | 29621 | — |
| Investigational Site Number 8404021 | Mt. Pleasant | South Carolina | 29464 | — |
| Investigational Site Number 8404056 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 8404015 | Austin | Texas | 78726-4061 | — |
| Investigational Site Number 8404050 | Austin | Texas | 78731 | — |
| Investigational Site Number 8404060 | Austin | Texas | 78749 | — |
| Investigational Site Number 8404005 | Beaumont | Texas | 77702 | — |
| Investigational Site Number 8404035 | Dallas | Texas | 75208 | — |
| Investigational Site Number 8404039 | Houston | Texas | 77058 | — |
| Investigational Site Number 8404055 | Houston | Texas | 77099 | — |
| Investigational Site Number 8404012 | Hurst | Texas | 76054 | — |
| Investigational Site Number 8404033 | Lampasas | Texas | 76550-1820 | — |
| Investigational Site Number 8404053 | McAllen | Texas | 78504 | — |
| Investigational Site Number 8404057 | Round Rock | Texas | 78681 | — |
| Investigational Site Number 8404059 | San Antonio | Texas | 78212 | — |
| Investigational Site Number 8404010 | San Antonio | Texas | 78249-2782 | — |
| Investigational Site Number 8404008 | Layton | Utah | 84041-1200 | — |
| Investigational Site Number 8404042 | Renton | Washington | 98057 | — |
| Investigational Site Number 8404041 | Seattle | Washington | 98105 | — |
| Investigational Site Number 8404047 | Kenosha | Wisconsin | 53144 | — |
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 119 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03242252, 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 25, 2021 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03242252 live on ClinicalTrials.gov.