Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
- Conditions
- MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Type 2 diabetes mellitusChronic kidney diseaseMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2017-002644-32-PT
- Lead Sponsor
- exicon Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16154
-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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method