A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Public ClinicalTrials.gov record NCT03242018. 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 Severe 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 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo
Study identification
- NCT ID
- NCT03242018
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 277 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
- May 16, 2019 (Actual)
- Completion
- Dec 11, 2019 (Actual)
- Last update posted
- Jun 25, 2021
2017 – 2019
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8405033 | Guntersville | Alabama | 35976-2206 | — |
| Investigational Site Number 8405005 | Phoenix | Arizona | 85018-2701 | — |
| Investigational Site Number 8405007 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 8405015 | Chula Vista | California | 91910 | — |
| Investigational Site Number 8405032 | La Jolla | California | 92037 | — |
| Investigational Site Number 8405003 | Norco | California | 92860-3611 | — |
| Investigational Site Number 8405013 | Northridge | California | 91324 | — |
| Investigational Site Number 8405018 | San Dimas | California | 91773 | — |
| Investigational Site Number 8405021 | Clearwater | Florida | 33761-2022 | — |
| Investigational Site Number 8405001 | DeLand | Florida | 32720-0834 | — |
| Investigational Site Number 8405043 | Miami | Florida | 33155-4630 | — |
| Investigational Site Number 8405006 | Ocoee | Florida | 34761-4547 | — |
| Investigational Site Number 8405025 | Ormond Beach | Florida | 32174-8187 | — |
| Investigational Site Number 8405039 | Lawrenceville | Georgia | 30046 | — |
| Investigational Site Number 8405041 | Arlington Heights | Illinois | 60005-4197 | — |
| Investigational Site Number 8405030 | Sellersburg | Indiana | 47172-8932 | — |
| Investigational Site Number 8405019 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 8405034 | Flint | Michigan | 48532-3447 | — |
| Investigational Site Number 8405012 | Norfolk | Nebraska | 68701-2669 | — |
| Investigational Site Number 8405035 | Albany | New York | 12206 | — |
| Investigational Site Number 8405027 | Laurelton | New York | 11413 | — |
| Investigational Site Number 8405014 | The Bronx | New York | 10455 | — |
| Investigational Site Number 8405037 | New Bern | North Carolina | 28562-5200 | — |
| Investigational Site Number 8405038 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 8405009 | Dayton | Ohio | 45419-4336 | — |
| Investigational Site Number 8405004 | Beaumont | Texas | 77702 | — |
| Investigational Site Number 8405036 | Dallas | Texas | 75208 | — |
| Investigational Site Number 8405020 | Houston | Texas | 77058 | — |
| Investigational Site Number 8405026 | Houston | Texas | 77099-4307 | — |
| Investigational Site Number 8405047 | Hurst | Texas | 76054 | — |
| Investigational Site Number 8405031 | San Antonio | Texas | 78215 | — |
| Investigational Site Number 8405016 | San Antonio | Texas | 78249-2782 | — |
| Investigational Site Number 8405008 | Layton | Utah | 84041-1200 | — |
| Investigational Site Number 8405040 | Winchester | Virginia | 22601 | — |
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 72 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03242018, 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 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03242018 live on ClinicalTrials.gov.