Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED)

Lexicon Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Diseases; Type 2 Diabetes Mellitus; Heart Failure

Treatments: Drug: Sotagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03315143

EFC14875

2017-002644-32

U1111-1187-8703 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10,584 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10,584 participants in 2 patient groups, including a placebo group

Sotagliflozin

Experimental group

Description:

Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.

Treatment:

Drug: Sotagliflozin

Placebo

Placebo Comparator group

Description:

Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.

Treatment:

Drug: Placebo