Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial

Tolerability of canagliflozin in patients with type 2 diabetes mellitus fasting during Ramadan: Results of the Canagliflozin in Ramadan Tolerance Observational Study (CRATOS)

“…While the insulin‐independent mechanism of canagliflozin leads to a low inherent risk of hypoglycaemia, the mild osmotic diuresis it causes may be associated with an increased risk of volume–depletion events, including dehydration. Across Phase 3 studies in a broad range of patients, canagliflozin provided reductions in HbA1c, body weight, and systolic blood pressure (BP) and was generally well tolerated, with a low risk of hypoglycaemia when not used in conjunction with insulin or sulphonylureas 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22. An analysis of T2DM patients living in hot climates found that canagliflozin treatment was generally well tolerated, with a low incidence of volume depletion–related AEs 23…”

Bioequivalence of Canagliflozin/Metformin Immediate Release Fixed- Dose Combination Tablets Compared with Concomitant Administration of Single Components of Canagliflozin and Metformin in Healthy Fed Participants

“…and 300 mg QD and were on stable metformin therapy at ≥2,000 mg/ day or ≥1,500 mg/day if unable to tolerate a higher dose [26,33,34]. In a drug-drug interaction study, healthy participants received single daily oral doses of canagliflozin 300 mg and metformin 2,000 mg, and no clinically meaningful interaction between the pharmacokinetics of either drug was observed suggesting that the two drugs could be combined into a single FDC tablet [35].…”

“…In the US, the patients with T2DM in Phase 3 pivotal studies received US-sourced Glucophage® or the generic equivalent. In the reported bioequivalence studies, the reference tablets were canagliflozin 100 and 300 mg and metformin was US sourced Glucophage® 500, 850 and 1000 mg tablets, thus providing support for bridging of the safety and efficacy data from prior clinical studies of canagliflozin and metformin co-administered monotherapies to the FDC tablet [25,26,33,34].…”

“…Findings from 52-week canagliflozin Phase 3 clinical studies in T2DM patients demonstrated favorable safety and tolerability of canagliflozin (100 or 300 mg) when administered concomitantly with metformin, metformin plus sulfonylurea, or metformin plus pioglitazone [24][25][26]33].…”

Effect of canagliflozin, a sodium–glucose cotransporter 2 inhibitor, on measurement of serum 1,5‐anhydroglucitol (坎格列净，一种钠‐葡萄糖共转运体2抑制剂，对血清1,5‐脱水葡萄糖醇测定的影响)

“…6 The efficacy of canagliflozin in improving glycemic control, as measured by reductions in HbA1c and fasting and postprandial plasma glucose (FPG and PPG, respectively), and the overall safety and tolerability profile of canagliflozin in patients with T2DM have been reported previously. [7][8][9][10][11][12][13] Herein we report findings from a post hoc analysis of 1,5-AG levels using archived samples from a subset of patients who participated in a randomized, double-blind, placebocontrolled, Phase 3 study of canagliflozin monotherapy in patients with T2DM. 7 Detailed methods from the Phase 3 study of canagliflozin monotherapy have been reported elsewhere.…”