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 |
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.
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.
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.
We found this trial at
101
sites
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