Clinical Trial identifier:
Saxagliptin 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
Article first published online: 25 JAN 2013
© 2013 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 67, Issue 4, pages 307–316, April 2013
How to Cite
Göke, B., Gallwitz, B., Eriksson, J. G., Hellqvist, Å. and Gause-Nilsson, I. (2013), Saxagliptin 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. International Journal of Clinical Practice, 67: 307–316. doi: 10.1111/ijcp.12119
The results of this study were presented in part at the American Diabetes Association 71st Scientific Sessions, San Diego, CA, June 24–28, 2011.
Dr Göke declares that he has served on an advisory board for AstraZeneca and received honoraria for speaking engagements with AstraZeneca, Eli Lilly and Company, Novartis and Novo Nordisk. Dr Gallwitz has served on advisory boards for AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly and Company, Novartis, Novo Nordisk, Nycomed, Merck & Co., Inc., Hoffman-La Roche Inc., sanofi-aventis and Takeda Pharmaceuticals and received honoraria for speaking engagements from these companies. Dr Eriksson has been an investigator or received honoraria for speaking engagements with AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Novartis, Novo Nordisk, Hoffman-La Roche Inc. and sanofi-aventis. Åsa Hellqvist, MSc, and Dr Gause-Nilsson are employees of AstraZeneca Research & Development.
- Issue published online: 24 MAR 2013
- Article first published online: 25 JAN 2013
- Manuscript Accepted: 27 DEC 2012
- Manuscript Received: 11 MAY 2012
- Bristol-Myers Squibb
To compare the long-term safety, tolerability and efficacy of saxagliptin vs. glipizide as add-on therapy to metformin.
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.
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.