Open AccessSaxagliptin vs. glipizide as add‐on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long‐term (52‐week) extension of a 52‐week randomised controlled trial
Author(s) -
Göke Burkhard,
Gallwitz Baptist,
Eriksson Johan G.,
Hellqvist Åsa,
GauseNilsson Ingrid
Publication year - 2013
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/ijcp.12119
Subject(s) - saxagliptin , glipizide , medicine , tolerability , metformin , type 2 diabetes , hypoglycemia , dipeptidyl peptidase 4 inhibitor , diabetes mellitus , adverse effect , pharmacology , gastroenterology , endocrinology , sitagliptin
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 (HbA 1c ) > 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 ( NCT 00575588). 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 AE s. 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 HbA 1c 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 HbA 1c ≥ 7% who achieved HbA 1c < 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 HbA 1c was observed with saxagliptin vs. glipizide as add‐on therapy to metformin.