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

• Register: EUCTR
• Last refreshed on: 9 November 2020
• Main ID: EUCTR2017-002644-32-NL
• Date of registration: 25/10/2017
• Prospective Registration: Yes
• Primary sponsor: SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
• Public title: Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
• Scientific title: 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
• Date of first enrolment: 14/02/2018
• Target sample size: 16154
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002644-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Desiree van de Rotten
• Affiliation: To be filled in locally

• Name: Desiree van de Rotten
• Affiliation: To be filled in locally

Key inclusion & exclusion 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) no
F.1.3.1 Number of subjects for this age range 6454

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 2 diabetes mellitus Chronic kidney disease
MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders

Intervention(s)

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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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.

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.

Timepoint(s) of evaluation of this end point: 1. and 2. Baseline to approximately 51 months

Secondary Outcome(s)

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

Secondary ID(s)

EFC14875

2017-002644-32-CZ

Source(s) of Monetary Support

SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT

Ethics review

Status: Approved
Approval date: 14/02/2018
Contact: