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

Phase 1

• Conditions: Type 2 diabetes mellitusChronic kidney disease; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 21.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002644-32-HU
• Lead Sponsor: exicon Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-09
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16154

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

-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