Canagliflozin-current status in the treatment of type 2 diabetes mellitus with focus on clinical trial data

Table 2 Summary of adverse events observed in the canagliflozin clinical trials

S. No	ClinicalTrials.gov identifier	Adverse events	Ref.
1	NCT01081834	Increased incidence of AEs in CFZ groups Serious AEs and AE related discontinuations similar in all groups Increased incidence of UTI, genital mycotic infections and osmotic diuresis related AEs in CFZ groups Moderate increase in BUN, serum creatinine and decrease in serum uric acid	Stenlöf et al[19]
2	NCT01106677	AEs similar across all groups Higher incidence of pollakiuria in CFZ groups -5.71% with 100 mg CFZ and 2.72% with 300 mg CFZ vs 0.55% of PL	[20]
3	NCT01106690	Vulvovaginal mycotic infections: 2.65% to 5.26% vs 0% of placebo Pollakiuria: 6.14% to 9.42% vs 0.87% of placebo Increased rate of hypoglycemic event with CFZ 300 mg (5.26% vs 1.74% of PL)	Guthrie et al[21]
4	NCT00968812	Osmotic diuresis related AEs in 3% of CFZ groups as compared to < 1% in placebo groups Genital infections and increase in LDL cholesterol more in CFZ groups	Cefalu et al[23]
5	NCT01106625	Superficial genital mycotic infection: 16.0% to 21.0% vs 5% in women and 3.4% to 6.6% vs 1.3% in men More subjects treated with CFZ had ≥ 1 hypoglycemic episodes	Wilding et al[24]
6	NCT01137812	Genital mycotic infections: 9.2% of CFZ 300 mg vs 0.5% of SITA Osmotic diuresis related AEs: 2.4% of CFZ 300 mg vs 1.3% of SITA Higher incidence of increased TG in CFZ groups	Schernthaner et al[25]
7	Not available	Similar rate of AEs and discontinuations across all groups No serious AEs	Devineni et al[26]
8	NCT00642278	Non dose dependent increase in incidence of genital infections (3%-8% vs 2% of SITA) and UTI (3%-9% vs 2% of SITA) in CFZ groups Low incidence of hypoglycemia Small increase in LDL cholesterol in CFZ groups	Rosenstock et al[27]
9	NCT01064414	AEs similar across all groups Increased incidence of hypoglycemic events in CFZ groups -14.44% with 100 mg CFZ and 11.24% with 300 mg CFZ vs 4.44% of PL	[28]

AEs: Adverse events; CFZ: Canagliflozin; UTI: Urinary tract infections; SITA: Sitagliptin; LDL: Low-density lipoprotein; PL: Placebo; TG: Triglycerides; BUN: Blood urea nitrogen.