Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

• Status: Terminated
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objectives:

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 patients with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

• Total occurrences of HHF and urgent visit for HF

• Occurrences of cardiovascular death

• Total occurrences of cardiovascular death, HHF, urgent HF visit, non-fatal stroke, and non-fatal myocardial infarction

• Total occurrences of cardiovascular death, HHF, urgent HF visit, and HF while hospitalized

• First occurrence of a sustained ≥50% decrease in estimated glomerular filtration rate (eGFR) from baseline (for ≥30 days), chronic dialysis, renal transplant or sustained eGFR <15 mL/min/1.73m2 (for ≥30 days)

• All-cause mortality

• Total occurrences of cardiovascular death, non-fatal stroke, and non-fatal myocardial infarction

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals; Sanofi
• Collaborator: Sanofi
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Criteria

Inclusion criteria :

• Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥ 7%.

• Estimated glomerular filtration rate (eGFR) ≥ 25 and ≤ 60 mL/min/1.73 m2.

• 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 patient's potential participation in a clinical trial.