Long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes and chronic kidney disease: A 52-week postmarketing clinical study (TWINKLE).

ABSTRACT:

Aim

To evaluate the long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes (T2D) and advanced chronic kidney disease (CKD).

Materials and methods

This open-label, single-arm, multicenter, phase 4 study (TWINKLE) enrolled individuals with T2D and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m², treated with ≤1 oral hypoglycemic agent. Participants received 500 mg of imeglimin twice daily if eGFR was 15 to <45 mL/min/1.73 m² or 500 mg once daily if eGFR was <15 mL/min/1.73 m², as monotherapy or in combination with their existing hypoglycemic agent, for 52 weeks. Dose adjustments were permitted based on safety and eGFR.

Results

Among 60 participants (CKD stages: G3b: n = 42; G4: n = 16; G5:

SUBMITTER: Babazono T 

PROVIDER: S-EPMC12489332 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature