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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:November 28, 2017
End Date:March 2022
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

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.

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.

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.
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