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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03315143
• Date of registration: 16/10/2017
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals
• 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 SCORED
• 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: November 28, 2017
• Target sample size: 10584
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03315143
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Suman Wason, MD
• Affiliation: Lexicon Pharmaceuticals, Inc.

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.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Diseases

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo

Drug: Sotagliflozin (SAR439954)

Primary Outcome(s)

Total occurrences of CV Death and Heart Failure Events [Time Frame: Baseline through a maximum of 33 months]

Secondary Outcome(s)

Total occurrences of 3-Point MACE plus HHF events [Time Frame: Baseline through a maximum of 33 months]

Time to composite renal event [Time Frame: Baseline through a maximum of 33 months]

CV Death [Time Frame: Baseline through a maximum of 33 months]

Total occurrences of Heart Failure Events [Time Frame: Baseline through a maximum of 33 months]

All-Cause Mortality [Time Frame: Baseline through a maximum of 33 months]

Total occurrences of 3-Point MACE [Time Frame: Baseline through a maximum of 33 months]

Total occurrences of CV Death, HF Events, and HF while hospitalized [Time Frame: Baseline through a maximum of 33 months]

Secondary ID(s)

EFC14875

2017-002644-32

U1111-1187-8703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi