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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Clin+Transl+Endocrinol
2014 ; 1
(2
): 54-60
Nephropedia Template TP
gab.com Text
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Twit Text #
English Wikipedia
Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose
co-transporter 2 inhibitor, added on to metformin monotherapy in patients with
type 2 diabetes mellitus
#MMPMID29159083
Qiu R
; Capuano G
; Meininger G
J Clin Transl Endocrinol
2014[Jun]; 1
(2
): 54-60
PMID29159083
show ga
AIM: To evaluate the efficacy/safety of canagliflozin twice daily (BID) compared
with placebo in patients with type 2 diabetes mellitus (T2DM) on metformin.
METHODS: In this 18-week, randomized, double-blind, placebo-controlled study,
patients (N = 279) at 60 centers in 7 countries received canagliflozin 50 or
150 mg or placebo BID. The pre-specified primary endpoint was change from
baseline in HbA(1c) at Week 18. Pre-specified secondary endpoints included
proportion of patients reaching HbA(1c) <7.0%, change in fasting plasma glucose
(FPG), and percent change in body weight; changes in systolic blood pressure (BP)
and fasting plasma lipids were also evaluated. Adverse events (AEs) were recorded
throughout the study. RESULTS: From a mean baseline HbA(1c) of 7.6%
(60 mmol/mol), canagliflozin 50 and 150 mg BID significantly reduced HbA(1c)
compared with placebo at Week 18 (-0.45%, -0.61%, -0.01% [-5, -7, -0.1 mmol/mol],
respectively; P < 0.001). More patients achieved HbA(1c) <7.0% with canagliflozin
than placebo (P < 0.05). Relative to placebo, both canagliflozin doses
significantly lowered FPG and body weight (P < 0.001), and reduced systolic BP.
Overall AE incidence was 35.5%, 40.9%, and 36.6% with canagliflozin 50 and 150 mg
BID and placebo, respectively. Canagliflozin was associated with increased
incidences of urinary tract infections, female genital mycotic infections, and
osmotic diuresis-related AEs; these led to few discontinuations. The incidence of
documented hypoglycemia was low across groups. CONCLUSIONS: Canagliflozin 50 and
150 mg BID provided significant glycemic efficacy and body weight reduction, and
were generally well tolerated in patients with T2DM on background
metformin.ClinicalTrials.gov Identifier: NCT01340664.