Trial reportJournal of diabetes investigation2025
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).
Trial report in Journal of diabetes investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Article
- Impact of renal function on antidiabetic drug selection in Japan: A real-world analysis using the J-DREAMS database.Journal of diabetes investigation · 2026Article
- Imeglimin may improve albuminuria associated with partial suppression of inflammatory and fibrotic markers in diabetic kidney disease.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
aimTo 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
methodsThis open-label, single-arm, multicenter, phase 4 study (TWINKLE) enrolled individuals with T2D and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m
resultsAmong 60 participants (CKD stages: G3b: n = 42; G4: n = 16; G5: n = 2), adverse events (AEs) occurred in 41 participants (68.3%), with no increased incidence across CKD stages. The most common AE was diarrhea (n = 6, 10.0%). Baseline mean (SD) HbA1c, glycated albumin (GA), and fasting plasma glucose (FPG) levels were 7.59% (0.68%), 22.53% (3.27%), and 151.8 (28.86) mg/dL, respectively. At week 24, mean (SD) changes from baseline were -0.53% (0.51%) for HbA1c, -2.37% (2.08%) for GA, and -13.6 (20.87) mg/dL for FPG. At week 52 (last observation carried forward [LOCF]), mean changes were -0.26% (0.88%), -1.59% (3.04%), and -7.0 (31.17) mg/dL. The proportion achieving HbA1c < 7.0% increased from 13.3% at baseline to 50.0% at week 52 (LOCF).
conclusionsThis study confirmed the favorable safety profile and sustained glycemic efficacy of imeglimin in Japanese individuals with T2D and CKD stages G3b-5, supporting its use with dose adjustment in this population.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.