Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
Public ClinicalTrials.gov record NCT03285594. 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, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)
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 in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs). Secondary Objectives: * To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c. * To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP. * To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
Study identification
- NCT ID
- NCT03285594
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 571 participants
Conditions and interventions
Conditions
Interventions
- Sotagliflozin Drug
- Insulin glargine (HOE901) Drug
- Placebo Drug
- Oral Antidiabetes Drugs (OADs) Drug
Drug
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
- Sep 15, 2017 (Actual)
- Primary completion
- Sep 17, 2019 (Actual)
- Completion
- Sep 27, 2019 (Actual)
- Last update posted
- May 11, 2021
2017 – 2019
United States locations
- U.S. sites
- 50
- U.S. states
- 18
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8406028 | Mesa | Arizona | 85213-5226 | — |
| Investigational Site Number 8406013 | Phoenix | Arizona | 85018 | — |
| Investigational Site Number 8406020 | Phoenix | Arizona | 85020 | — |
| Investigational Site Number 8406006 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8406053 | Lincoln | California | 95648 | — |
| Investigational Site Number 8406040 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8406043 | Coral Gables | Florida | 33134 | — |
| Investigational Site Number 8406008 | DeLand | Florida | 32720 | — |
| Investigational Site Number 8406030 | Maitland | Florida | 32751 | — |
| Investigational Site Number 8406003 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 8406029 | North Miami Beach | Florida | 33162 | — |
| Investigational Site Number 8406052 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8406001 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 8406022 | St. Petersburg | Florida | 33700 | — |
| Investigational Site Number 8406025 | Tampa | Florida | 33634 | — |
| Investigational Site Number 8406002 | West Palm Beach | Florida | 33401-3430 | — |
| Investigational Site Number 8406054 | Chicago | Illinois | 60602 | — |
| Investigational Site Number 8406027 | Chicago | Illinois | 60604 | — |
| Investigational Site Number 8406042 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 8406044 | New Orleans | Louisiana | 70119-6302 | — |
| Investigational Site Number 8406051 | New Orleans | Louisiana | 70124 | — |
| Investigational Site Number 8406024 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 8406016 | Detroit | Michigan | 48202 | — |
| Investigational Site Number 8406011 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 8406010 | Papillion | Nebraska | 68046-3136 | — |
| Investigational Site Number 8406018 | New York | New York | 10016-6023 | — |
| Investigational Site Number 8406034 | Asheville | North Carolina | 28803 | — |
| Investigational Site Number 8406046 | Chapel Hill | North Carolina | 27517 | — |
| Investigational Site Number 8406026 | Charlotte | North Carolina | 28209 | — |
| Investigational Site Number 8406038 | Greenville | North Carolina | 27834 | — |
| Investigational Site Number 8406036 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 8406015 | Wilmington | North Carolina | 28401-6638 | — |
| Investigational Site Number 8406019 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 8406031 | Beachwood | Ohio | 44122 | — |
| Investigational Site Number 8406023 | Columbus | Ohio | 43201 | — |
| Investigational Site Number 8406005 | Dublin | Ohio | 43016 | — |
| Investigational Site Number 8406004 | Mentor | Ohio | 44060 | — |
| Investigational Site Number 8406033 | Oklahoma City | Oklahoma | 73111 | — |
| Investigational Site Number 8406032 | Moncks Corner | South Carolina | 29461-5017 | — |
| Investigational Site Number 8406009 | Chattanooga | Tennessee | 37421 | — |
| Investigational Site Number 8406045 | Seymour | Tennessee | 37865-5270 | — |
| Investigational Site Number 8406047 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8406017 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8406048 | Houston | Texas | 77079 | — |
| Investigational Site Number 8406037 | Houston | Texas | 77099 | — |
| Investigational Site Number 8406039 | McAllen | Texas | 78504 | — |
| Investigational Site Number 8406050 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 8406021 | Shavano Park | Texas | 78231 | — |
| Investigational Site Number 8406035 | Salt Lake City | Utah | 84102-1553 | — |
| Investigational Site Number 8406014 | West Jordan | Utah | 84088-8865 | — |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03285594, 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 11, 2021 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03285594 live on ClinicalTrials.gov.