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Summary

Aim

To compare the long-term safety, tolerability and efficacy of saxagliptin vs. glipizide as add-on therapy to metformin.

Methods

Adults with glycated haemoglobin (HbA1c) > 6.5–10% (on stable metformin ≥ 1500 mg/day) were randomised to saxagliptin 5 mg/day (n = 428) or glipizide titrated from 5 to 20 mg/day (mean dose 15 mg/day; n = 430) for 52 weeks with a 52-week extension (NCT00575588). Assessment of the long-term safety, tolerability and efficacy of add-on saxagliptin vs. glipizide after 104 weeks was a tertiary objective of the initial 52-week study.

Results

Saxagliptin was well tolerated during the 104-week period; 67.1% of patients receiving saxagliptin vs. 72.6% receiving glipizide had ≥ 1 adverse event (AE), and few patients (4.9% vs. 5.6%) discontinued owing to AEs. Fewer patients treated with saxagliptin experienced hypoglycaemia (3.5% vs. 38.4% with glipizide; difference, −34.9%, 95% CI, −39.8 to −30.0) or confirmed hypoglycaemia (0 vs. 9.1% with glipizide). Weight loss was observed with saxagliptin (−1.5 kg) vs. weight gain with glipizide (+1.3 kg; between-group difference, −2.8 kg, 95% CI, −3.32 kg to −2.20 kg). Change from baseline in HbA1c was −0.41 ± 0.04% with saxagliptin and −0.35 ± 0.04% with glipizide (between-group difference, −0.05%, 95% CI, −0.17 to 0.06%). A post hoc analysis showed that the proportion of patients with baseline HbA1c ≥ 7% who achieved HbA1c < 7% (observed data) at week 104 was 23.1% for saxagliptin + metformin and 22.7% for glipizide + metformin.

Discussion and Conclusion

A lower risk of hypoglycaemia and reduced body weight were observed with saxagliptin vs. glipizide. No other clinically significant differences were observed between groups in safety profile. No significant between-group differences were observed for reductions in glycaemic parameters. After week 24, a smaller weekly rise in HbA1c was observed with saxagliptin vs. glipizide as add-on therapy to metformin.