Safety of anagliptin/metformin combination tablets evaluated by non-inferiority between pre- and post-serum lactic acid levels in Japanese patients with type 2 diabetes and moderate renal impairment (AMELIO STUDY)
Abstract
AIMS/INTRODUCTION: To investigate the safety of anagliptin/metformin combination tablets by evaluation of lactic acid levels in Japanese patients with type 2 diabetes and moderate renal impairment.
MATERIALS AND METHODS: The participants of type 2 diabetes with creatinine-based eGFR (eGFRcr) of ≥45 and <60 (mL/min/1.73 m2) (Group G3a) received anagliptin/metformin combination LD tablets (anagliptin: 100 mg, metformin hydrochloride: 250 mg/tablet) twice a day for 4 weeks. After 4 weeks, they received anagliptin/metformin combination HD tablets (anagliptin: 100 mg, metformin hydrochloride: 500 mg/tablet) twice daily until after 16 weeks. The participants (Group G3b) with baseline eGFRcr ≥30 and <45 (mL/min/1.73 m2) received anagliptin/metformin combination LD tablets twice daily for 16 weeks. The serum lactic acid levels were examined at weeks 4, 8, and 16 after receiving anagliptin/metformin combination tablets.
RESULTS: The change in serum lactic acid levels from baseline to 16 weeks was -0.09 [-0.28, 0.10] mmol/L (mean [95% confidence intervals]), not exceeding the pre-specified non-inferiority margin (0.7 mmol/L). No significant differences occurred in the change in serum lactic acid levels during all observation periods. Serum lactic acid levels exceeded 2.5 mmol/L in four participants (10.5%) and 5.0 mmol/L in one participant (2.6%) during the observation period. No participant had a plasma metformin exceeding 2.5 μg/mL.
CONCLUSIONS: This study demonstrates that the…
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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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