Efficacy and safety of combining olorigliflozin with metformin in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
Abstract
Objective: To evaluate the efficacy and safety of combining olorigliflozin with metformin in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin monotherapy. Methods: This study was a multicenter, randomized, double-blind, parallel, placebo-controlled phase Ⅲ clinical trial. A total of 390 T2DM patients with inadequately controlled blood glucose and receiving oral metformin were prospectively enrolled from 62 research centers nationwide between February 2021 and June 2023. Using a block randomization method stratified by baseline glycated hemoglobin A1c (HbA1c) results (≤8.5% and>8.5%), patients were randomly allocated in a 1∶1∶1 ratio via an interactive response system to the placebo group, olorigliflozin 20 mg group, and olorigliflozin 50 mg group. All patients were treated with metformin in combination for 24 consecutive weeks. After 24 weeks of treatment, patients in the placebo group were randomly reassigned in a 1∶1 ratio using the aforementioned randomization method to either the placebo-to-olorigliflozin 20 mg group or the placebo-to-olorigliflozin 50 mg group, entering a 28-week extended treatment period. Patients in the olorigliflozin 20 mg and 50 mg groups maintained their original treatment regimens. The primary efficacy endpoint was the change in HbA1c from baseline at week 24, analyzed using the full analysis set. Secondary efficacy endpoints included the change in HbA1c from baseline at week 52 and HbA1c target achievement rates…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 390 participants or records.
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