2013
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial
Abstract: AimsCanagliflozin is a sodium glucose co-transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). This randomised, double-blind, placebo-controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add-on to metformin plus sulphonylurea in patients with T2DM.MethodsPatients (N = 469) received canagliflozin 100 or 300 mg or placebo once daily during a 26-week core period and a 26-week extension. Prespecified primary end-point was change in HbA1c at 26 weeks. …
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Cited by 313 publications
(442 citation statements)
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Section: Discussionsupporting
confidence: 93%
“……”
Section: Discussionsupporting
confidence: 93%
“…In this study, population with a mean duration of T2DM of 10.5 years, canagliflozin was associated with significant improvements in HOMA2‐%B, an indirect measure of β‐cell function, compared with placebo at week 26, with sustained effects seen over 52 weeks of treatment. These findings are consistent with those observed in previous studies evaluating canagliflozin in patients with T2DM as well as preclinical effects observed with other SGLT2 inhibitors . It has been suggested that prevention of glucose toxicity (e.g.…”
Section: Discussionsupporting
confidence: 92%
“…The overall incidence of AEs was lower across groups in this study compared with previous studies (11-23); the reason for this observation, which has been seen with other AHAs (41,42), is not known but may be related to the characteristics of the study population. The pattern of specific AEs observed with CANA in this study was consistent with previous reports (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23), with a higher incidence of AEs related to the mechanism of SGLT2 inhibition (e.g., genital mycotic infections, volume depletion-related AEs, osmotic diuresis-related AEs) observed in all CANA treatment arms versus MET. No differences in gastrointestinal-related AEs were observed with combination therapy compared with MET monotherapy.…”
Section: Discussionsupporting
confidence: 92%
