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. 2016 Sep;7(3):527-35.
doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment

Shira Perl  1 , William Cook  2 , Cheryl Wei  3 , Nayyar Iqbal  3 , Boaz Hirshberg  2
Affiliations

Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment

Shira Perl et al. Diabetes Ther. 2016 Sep.

Abstract

Introduction: Type 2 diabetes (T2D) is the leading cause of chronic kidney disease (CKD). The recommended dose of the dipeptidyl peptidase-4 inhibitor saxagliptin is 2.5 mg in patients with moderate or severe renal impairment (creatinine clearance ≤50 mL/min). In this post hoc analysis, we assessed the effect of saxagliptin 2.5 and 5 mg/day versus placebo on glycemic measures in patients with T2D and estimated glomerular filtration rate 45-60 mL/min/1.73 m(2).

Methods: Efficacy and safety data were pooled from nine 24-week, randomized, placebo-controlled clinical trials.

Results: The majority (56-61%) of patients were women aged <65 years with glycated hemoglobin (A1C) 8.1-8.2%; half of the patients had a T2D duration ≥5 years. Mean change from baseline in A1C was significantly greater with saxagliptin 2.5 (-0.6%, P = 0.036 vs placebo) and 5 mg/day (-0.9%, P < 0.001 vs placebo) compared with placebo (-0.2%). There were numerically greater reductions in fasting plasma glucose and 2-h postprandial glucose, and a significantly greater proportion of patients achieved A1C <7% with saxagliptin 5 mg/day (44.8%) compared with placebo (20.0%, P = 0.004 vs placebo). The incidence of hypoglycemia was not significantly different across groups (16.2% in the saxagliptin 5-mg/day, 12.2% in the saxagliptin 2.5-mg/day, and 11.3% in the placebo groups).

Conclusion: These results suggest that saxagliptin 2.5 and 5 mg/day improve glycemic control and are generally well tolerated in patients with T2D and moderate CKD.

Trial registration: ClinicalTrials.gov identifier, NCT00121641, NCT00316082, NCT00698932, NCT00918879, NCT00121667, NCT00661362, NCT00313313, NCT00295633, NCT00757588.

Funding: AstraZeneca, Gaithersburg, MD, USA.

Keywords: Chronic kidney disease; Dipeptidyl peptidase-4 inhibitor; Estimated glomerular filtration rate; Saxagliptin; Type 2 diabetes.

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Figures

Fig. 1
Fig. 1
Mean change from baseline to week 24 in a A1C, b FPG, and c 2-h PPG. A1C glycated hemoglobin, FPG fasting plasma glucose, NS nonsignificant, PPG 2-h postprandial glucose, SAXA saxagliptin, SD standard deviation
Fig. 2
Fig. 2
Proportion of patients achieving A1C <7% at week 24. A1C glycated hemoglobin, NS nonsignificant, SAXA saxagliptin
Fig. 3
Fig. 3
Mean eGFR at baseline and 24 weeks. Mean (SD) change from baseline is shown above the bars. eGFR estimated glomerular filtration rate, SAXA saxagliptin, SD standard deviation
See this image and copyright information in PMC

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