Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Public ClinicalTrials.gov record NCT03386344. 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 26-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study With a 78-week Extension Period to Evaluate the Efficacy and Bone Safety of Sotagliflozin in Patients 55 Years or Older With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.
Study identification
- NCT ID
- NCT03386344
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 376 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 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 18, 2018
- Primary completion
- May 21, 2019
- Completion
- May 29, 2020
- Last update posted
- Jun 24, 2021
2018 – 2020
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8409009 | Escondido | California | 92025 | — |
| Investigational Site Number 8409010 | Greenbrae | California | 94904 | — |
| Investigational Site Number 8409005 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 8409012 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 8409011 | Evansville | Indiana | 47714-8011 | — |
| Investigational Site Number 8409014 | Wichita | Kansas | 67205-1138 | — |
| Investigational Site Number 8409015 | Albuquerque | New Mexico | 87106 | — |
| Investigational Site Number 8409002 | Chapel Hill | North Carolina | 27517 | — |
| Investigational Site Number 8409001 | Wilmington | North Carolina | 28401-6638 | — |
| Investigational Site Number 8409008 | Dayton | Ohio | 45419-4336 | — |
| Investigational Site Number 8409004 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 8409013 | Austin | Texas | 78749 | — |
| Investigational Site Number 8409003 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8409007 | Katy | Texas | 77450 | — |
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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03386344, 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 24, 2021 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03386344 live on ClinicalTrials.gov.