Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes a… (NCT03315143) | Clinical Trial Compass
TerminatedPhase 3
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Stopped: study terminated due to business decision
United States, Argentina, Australia10,584 participantsStarted 2017-12-19
Plain-language summary
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria :
* Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.
* Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute (mL/min)/1.73 square meter (m\^2).
* Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
* Signed written informed consent.
Exclusion criteria:
* Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
* Planned coronary procedure or surgery after randomization.
* Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
* Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)