A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Summary
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo
Timeline
- Start
- 2017-08-16
- Primary completion
- 2019-05-16
- Completion
- 2019-12-11
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Sotagliflozin 400 mg; p = 0.0962; Difference in Least Square (LS) Means -0.29 (95% CI -0.628 to 0.051); ANCOVA NCT03242018 ↗
paper After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant versus placebo in adults with T2D and CKD4. PMID 34338408 ↗
Publications
- Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Carroll AK, Lapuerta P, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment. Diabetes Obes Metab. 2021 Dec;23(12):2632-2642. doi: 10.1111/dom.14513. Epub 2021 Aug 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotagliflozin | Small molecule | 200 mg | Oral |
| Subject | Sotagliflozin | Small molecule | 400 mg | Oral |