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OBJECTIVE	There are limited data about the effects of sodium-glucose cotransporter 2 inhibitors when used with insulin .
OBJECTIVE	We report the efficacy and safety of canagliflozin in patients with type 2 diabetes using insulin .
METHODS	The CANagliflozin CardioVascular Assessment Study is a double-blind , placebo-controlled study that randomized participants to placebo , canagliflozin 100 mg , or canagliflozin 300 mg once daily , added to a range of therapies .
METHODS	The primary end point of this substudy was the change in HbA1c from baseline at 18 weeks among patients using insulin ; 52-week effects were also examined .
RESULTS	Individuals receiving insulin at baseline were randomized to receive placebo ( n = 690 ) , canagliflozin 100 mg ( n = 692 ) , or canagliflozin 300 mg ( n = 690 ) .
RESULTS	These individuals were 66 % male and had a median age of 63 years , mean HbA1c of 8.3 % ( 67 mmol/mol ) , BMI of 33.1 kg/m ( 2 ) , estimated glomerular filtration rate of 75 mL/min/1 .73 m ( 2 ) , fasting plasma glucose of 9.2 mmol/L , and a median daily insulin dose of 60 IU .
RESULTS	Most individuals were using basal/bolus insulin .
RESULTS	Reductions in HbA1c with canagliflozin 100 and 300 mg versus placebo were -0.62 % ( 95 % CI -0.69 , -0.54 ; -6.8 mmol/mol [ 95 % CI -7.5 , -5.9 ] ; P < 0.001 ) and -0.73 % ( 95 % CI -0.81 , -0.65 ; -8.0 mmol/mol [ 95 % CI -8.9 , -7.1 ] ; P < 0.001 ) at 18 weeks and -0.58 % ( 95 % CI -0.68 , -0.48 ; -6.3 mmol/mol [ 95 % CI -7.4 , -5.2 ] ) and -0.73 % ( 95 % CI -0.83 , -0.63 ; -8.0 mmol/mol [ 95 % CI -9.1 , -6.9 ] ) at 52 weeks .
RESULTS	There were significant falls in fasting plasma glucose , body weight , and blood pressure at both time points and there was a greater incidence of hypoglycemia , genital mycotic infections , and hypovolemia with both canagliflozin doses .
CONCLUSIONS	Canagliflozin added to insulin therapy improved glycemic control and decreased body weight .
CONCLUSIONS	There was a greater frequency of several anticipated side effects , although few led to discontinuation of treatment .

