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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002644-32-LV

Enrollment

16154

Registered

2017-10-04

Start date

2017-12-01

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Chronic kidney disease MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 21.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Sotagliflozin Product Code: SAR439954 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SOTAGLIFLOZIN CAS Number: 1018899-04-1 Current Sponsor code: SAR439954 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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.. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6454

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that, when compared to placebo in patients with type 2 diabètes (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 Objective: -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.;Primary end point(s): 1. Time to first Major Adverse Cardiovascular Event (MACE) : Time to the first occurrence of any of the following clinical events: Cardiovascular death, Non-fatal myocardial infarction (MI), Non-fatal stroke 2. Time to cardiovascular death or hospitalization for heart failure : Time to the first occurrence of any of the following clinical events: Cardiovascular death; Hospitalization for heart failure;Timepoint(s) of evaluation of this end point: 1. and 2. Baseline to approximately 51 months	—

Measure

Time frame

Main Objective: To demonstrate that, when compared to placebo in patients with type 2 diabètes (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 Objective: -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.;Primary end point(s): 1. Time to first Major Adverse Cardiovascular Event (MACE) : Time to the first occurrence of any of the following clinical events: Cardiovascular death, Non-fatal myocardial infarction (MI), Non-fatal stroke 2. Time to cardiovascular death or hospitalization for heart failure : Time to the first occurrence of any of the following clinical events: Cardiovascular death; Hospitalization for heart failure;Timepoint(s) of evaluation of this end point: 1. and 2. Baseline to approximately 51 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time to first composite renal event : Time to the first occurrence of any of the following clinical events in patients with baseline eGFR =30 mL/min/1.73 m2: Sustained =50% decrease of eGFR from baseline (for =30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for =30 days) 2. Time to first composite renal event in subgroup of patients with macroalbuminuria : Time to the first occurrence of any of the following clinical events in patients with baseline eGFR =30 mL/min/1.73 m2 and baseline UACR =300 mg/g: Sustained =50% decrease of eGFR from baseline (for =30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for =30 days 3. Total number of heart failure events : Total number (ie, including recurrent events) of the following clinical events: Cardiovascular death, Hospitalization for heart failure; Urgent heart failure visit 4. Cardiovascular (CV) death : Time to CV death 5. All cause mortality : Time to all-cause mortality;Timepoint(s) of evaluation of this end point: 1. to 5. Baseline to approximately 51 months	—

Measure

Time frame

Secondary end point(s): 1. Time to first composite renal event : Time to the first occurrence of any of the following clinical events in patients with baseline eGFR =30 mL/min/1.73 m2: Sustained =50% decrease of eGFR from baseline (for =30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for =30 days) 2. Time to first composite renal event in subgroup of patients with macroalbuminuria : Time to the first occurrence of any of the following clinical events in patients with baseline eGFR =30 mL/min/1.73 m2 and baseline UACR =300 mg/g: Sustained =50% decrease of eGFR from baseline (for =30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for =30 days 3. Total number of heart failure events : Total number (ie, including recurrent events) of the following clinical events: Cardiovascular death, Hospitalization for heart failure; Urgent heart failure visit 4. Cardiovascular (CV) death : Time to CV death 5. All cause mortality : Time to all-cause mortality;Timepoint(s) of evaluation of this end point: 1. to 5. Baseline to approximately 51 months

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Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactExecutive Director, Clinical Ops

Lexicon Pharmaceuticals, Inc.

medical-information@lexpharma.com+1281863-3000,

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026