Disclosures Dr Chacra has served as a member of the Latin American Diabetes Advisory Board for Bristol-Myers Squibb and AstraZeneca. Dr Tan has served on advisory boards for the Philippine affiliates of Novo Nordisk and sanofi-aventis and received honoraria for speaking engagements from the Philippine affiliates of Eli Lilly, Novo Nordisk, Novartis, sanofi-aventis and Merck. Drs Apanovitch, Ravichandran, List and Chen are employees of Bristol-Myers Squibb.
Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial
Article first published online: 15 JUL 2009
© 2009 Bristol-Myers Squibb. Journal compilation © 2009 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 63, Issue 9, pages 1395–1406, September 2009
How to Cite
Chacra, A. R., Tan, G. H., Apanovitch, A., Ravichandran, S., List, J., Chen, R. and for the CV181-040 Investigators (2009), Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. International Journal of Clinical Practice, 63: 1395–1406. doi: 10.1111/j.1742-1241.2009.02143.x
Trial Registration ClinicalTrials.gov ID no.: NCT 00313313.
Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://www3.interscience.wiley.com/authorresources/onlineopen.html
- Issue published online: 10 AUG 2009
- Article first published online: 15 JUL 2009
- Paper received May 2009, accepted June 2009
Vol. 64, Issue 2, 277, Article first published online: 11 DEC 2009
Aims: Assess the efficacy and safety of saxagliptin added to a submaximal sulphonylurea dose vs. uptitration of sulphonylurea monotherapy in patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy.
Methods and patients: A total of 768 patients (18–77 years; HbA1c screening ≥ 7.5 to ≤ 10.0%) were randomised and treated with saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg vs. glyburide 10 mg for 24 weeks. Blinded uptitration glyburide was allowed in the glyburide-only arm to a maximum total daily dose of 15 mg. Efficacy analyses were performed using ANCOVA and last-observation-carried-forward methodology.
Results: At week 24, 92% of glyburide-only patients were uptitrated to a total glyburide dose of 15 mg/day. Saxagliptin 2.5 and 5 mg provided statistically significant adjusted mean decreases from baseline to week 24 vs. uptitrated glyburide, respectively, in HbA1c (−0.54%, −0.64% vs. +0.08%; both p < 0.0001) and fasting plasma glucose (−7, −10 vs. +1 mg/dl; p = 0.0218 and p = 0.002). The proportion of patients achieving an HbA1c < 7% was greater for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide (22.4% and 22.8% vs. 9.1%; both p < 0.0001). Postprandial glucose area under the curve was reduced for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide (−4296 and −5000 vs. +1196 mg·min/dl; both p < 0.0001). Adverse event occurrence was similar across all groups. Reported hypoglycaemic events were not statistically significantly different for saxagliptin 2.5 (13.3%) and 5 mg (14.6%) vs. uptitrated glyburide (10.1%).
Conclusion: Saxagliptin added to submaximal glyburide therapy led to statistically significant improvements vs. uptitration of glyburide alone across key glycaemic parameters and was generally well tolerated.