Saxagliptin Responder Analysis: A Pooled Analysis of 5 Clinical TrialsMikaela Sjostrand1, Gil Leibowitz2, Nayyar Iqbal3, William Cook3, Cheryl Wei3 and Boaz Hirshberg4*
- Corresponding Author:
- Boaz Hirshberg
Clinical Therapeutic Area Head
Cardiovascular/Metabolic Disease (CVMD) MedImmune
LLC One MedImmune Way, Building 200 Gaithersburg, MD 20878, USA
Fax: (301) 398-9865
E-mail: [email protected]
Received Date: October 09, 2015; Accepted March 10, 2016; Published Date: March 17, 2016
Citation: Sjostrand M, Leibowitz G, Iqbal N, Cook W, Wei C, et al. (2016) Saxagliptin Responder Analysis: A Pooled Analysis of 5 Clinical Trials. J Diabetes Metab 7:657. doi:10.4172/2155-6156.1000657
Copyright: © 2016 Sjostrand M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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). Results: The adjusted mean change [95% CI] from baseline to week 24 in HbA1c with saxagliptin was greatest in responders (–1.05% [–1.11%, – 0.99%]) followed by intermediate responders (–0.32% [–0.43%, –0.22%]) and nonresponders (0.27% [0.18%, 0.36%]). The proportion of patients achieving HbA1c<7% after 24 weeks was greater in responders (48%) and intermediate responders (41%) versus nonresponders (22%, P<0.0001 for each). The adjusted mean increase from baseline to week 24 in HOMA-2%β was greatest in the responder group (16.9% [13.5%, 20.2%]) compared with the other groups (intermediate responders, 11.7% [5.9%, 17.5%]; nonresponders, 0.4% [–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). 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.