Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks

Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks

Author Chacra, Antonio R. Autor UNIFESP Google Scholar
Tan, Gerry H. Google Scholar
Ravichandran, Shoba Google Scholar
List, James Google Scholar
Chen, Roland Google Scholar
CV181040 Investigators Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Cebu Doctors Univ
Abstract To assess the long-term efficacy and safety of saxagliptin in patients with type 2 diabetes mellitus inadequately controlled on sulphonylurea monotherapy, 768 patients were randomised to saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg versus placebo added to up-titrated glyburide over 76 weeks (24 weeks plus 52-week extension) in this phase 3, double-blind, placebo-controlled trial; 557 patients completed the study, 142 without being rescued. At 76 weeks, adjusted mean changes from baseline HbA(1C) (repeated measures model) (95% confidence interval) for saxagliptin 2.5 mg, saxagliptin 5 mg, and up-titrated glyburide were 0.11% (-0.05, 0.27), 0.03% (-0.14, 0.19), and 0.69% (0.47, 0.92), respectively (post hoc and nominal p < 0.0001 for saxagliptin 2.5 and 5 mg vs. up-titrated glyburide). Adverse event frequency was similar in all treatment groups; reported hypoglycaemia event rates were 24.2%, 22.9%, and 20.6% with saxagliptin 2.5 mg, saxagliptin 5 mg, and up-titrated glyburide, respectively. Saxagliptin plus glyburide provided sustained incremental efficacy compared with up-titrated glyburide over 76 weeks, and was generally well tolerated.
Keywords Dipeptidyl peptidase-4
DPP-4 inhibitor
HbA(1C)
saxagliptin
sulphonylurea
type 2 diabetes mellitus
Language English
Sponsor Bristol-Myers Squibb
AstraZeneca
Date 2011-04-01
Published in Diabetes & Vascular Disease Research. London: Sage Publications Ltd, v. 8, n. 2, p. 150-159, 2011.
ISSN 1479-1641 (Sherpa/Romeo, impact factor)
Publisher Sage Publications Ltd
Extent 150-159
Origin http://dx.doi.org/10.1177/1479164111404574
Access rights Closed access
Type Article
Web of Science ID WOS:000292119600007
URI http://repositorio.unifesp.br/handle/11600/33623

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