Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Summary

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

Timeline

Start

2017-08-16

Primary completion

2019-03-25

Completion

2019-10-25

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p = 0.2095; Difference in Least Squares (LS) Means -0.1 (95% CI -0.245 to 0.054); ANCOVA NCT03242252 ↗

registry analysis (superiority test); Placebo vs Sotagliflozin 400 mg; p = 0.0021; Difference in LS Means -0.24 (95% CI -0.386 to -0.085); ANCOVA NCT03242252 ↗

paper CONCLUSIONS: After 26 weeks, HbA1c was significantly reduced with sotagliflozin 400 but not 200 mg compared with placebo in this CKD3 cohort. PMID 36782093 ↗

Publications

• Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Powell DR, Davies MJ, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. Diabetes Obes Metab. 2023 Jun;25(6):1646-1657. doi: 10.1111/dom.15019. Epub 2023 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sotagliflozin	Small molecule	200 mg	Oral
Subject	Sotagliflozin	Small molecule	400 mg	Oral

Indications