Last updated on October 2018

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


Brief description of study

Primary Objectives:

To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D), cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin:

  • Does not increase the risk of cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;
  • Reduces the risk of death from CV disease or hospitalization for heart failure.

Secondary Objectives:

  • To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and moderately impaired renal function, sotagliflozin:
  • Reduces cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;
  • Reduces risk of progression of kidney disease;
  • Reduces cardiovascular events including death from cardiovascular disease and emergency treatment for heart failure;
  • Reduces death from cardiovascular disease;
  • Reduces death from any cause.
  • To assess the safety and tolerability of sotagliflozin.

Detailed Study Description

Study duration per participant is approximately 27 to 51 months, assuming approximately 24 months of recruitment, and approximately 27 months of follow-up after the last patient is randomized.

Clinical Study Identifier: NCT03315143

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Investigational Site Number 8400106
Opa-locka, FL United States
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Hialeah, FL United States
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North Miami Beach, FL United States
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Cooper City, FL United States
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Miami, FL United States
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Miami, FL United States
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Miami, FL United States
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