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

Conditions

• Chronic Kidney Diseases
• Heart Failure
• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sotagliflozin — DRUG
  Sotagliflozin was administered as a tablet(s), orally once daily.
• Placebo — DRUG
  Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Study Details

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.

Key Dates

Start date

Dec 19, 2017

Status verified

Sep 2022

Primary completion

Jul 8, 2020

Completion

Jul 8, 2020

Study Design

Enrollment

10,584 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

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

Primary Outcome Measure

Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) [ Time Frame: Up to 30 months ]

Locations (119)

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