Saxagliptin Responder Analysis: A Pooled Analysis of 5 Clinical Trials

Abstract

Objective: To assess the treatment response of patients with T2DM to saxagliptin at 24 weeks based on their initial response to saxagliptin at 12 weeks.Methods: Data were pooled from five 24-week, randomized, placebo-controlled trials of saxagliptin. Patients (N=1994) were categorized by change in glycated hemoglobin (HbA1c) after 12 weeks of saxagliptin treatment as responders (HbA1c decrease ≥ 0.5%; 61% of saxagliptin-treated patients), intermediate responders (HbA1c decrease ≥ 0.2% and <0.5%; 14% of patients), and nonresponders (HbA1c decrease <0.2%; 25% of patients). [-4.8%, 5.6%]). Baseline characteristics that were associated with glycemic response to saxagliptin included higher baseline HbA1c (P<0.0001), higher HOMA-2%β (P<0.0001), lower fasting insulin (P=0.0006), shorter T2DM duration (P=0.033), and male sex (P=0.031). Results Conclusion:Responders, who comprised 61% of saxagliptin-treated patients analyzed, derived significant benefit from saxagliptin, with a ~1% decline in HbA1c and increased β-cell function at 24 weeks compared with nonresponders.

Impact of baseline characteristics on glycemic effects of add‐on saxagliptin or acarbose to metformin therapy: Subgroup analysis of the SMART study in Chinese patients with type 2 diabetes mellitus

“…This discrepancy in FPG‐lowering effect was not observed previously in the SUNSHINE study with a larger sample size ( n = 1,423), which showed a consistent reduction in FPG across all BMI subgroups (≥28 kg/m 2 , −0.49 mmol/L; ≥24 to <28 kg/m 2 , −0.62 mmol/L; <24 kg/m 2 , −0.50 mmol/L) 9 . In addition, a pooled analysis of five randomized clinical trials ( n = 1,994) showed no association between BMI and glycemic response to saxagliptin treatment 14 . In contrast, a meta‐analysis of 55 studies by Kim et al 15 .…”