After 2 years' treatment with empagliflozin 25 mg as add-on to metformin, approximately 90% of the weight loss observed was due to fat loss [ 32].
The second (Study 2) [ 18] studied canagliflozin 100 and 300 mg as add-on therapy to metformin plus a sulfonylurea compared with placebo at 26 weeks; and the third (Study 3) [ 15] studied canagliflozin 300 mg as add-on therapy to metformin plus a sulfonylurea compared with sitagliptin 100 mg at 52 weeks.
Despite these limitations, the results of this analysis suggest that the long-term use of saxagliptin 5 mg as add-on therapy to metformin, a thiazolidinedione, or glyburide is generally well tolerated in older, relatively healthy patients with T2DM.
Both doses of saxagliptin (2.5 mg and 5 mg) as add-on to a glitazone led to statistically significant adjusted mean decreases in HbA1c vs placebo (−0.66% and −0.94% for saxagliptin 2.5 mg and 5 mg vs −0.30% for placebo).
Study 3 (ClinicalTrials.gov identifier NCT01137812) [ 15] was a 52 week, randomised, double-blind, active-controlled, Phase 3 study comparing canagliflozin 300 mg with sitagliptin 100 mg as add-on therapy to metformin plus sulfonylurea.
The objective of this study was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy to common antihyperglycemic drugs in patients aged ≥65 years and <65 years.
The objective of this analysis was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy in patients aged ≥65 years and <65 years.
This 52-week Canagliflozin Treatment and Trial Analysis dipeptidyl peptidase-4 inhibitor (CANTATA-D2; second comparator trial) study evaluated the efficacy and safety of canagliflozin 300 mg compared with sitagliptin 100 mg as add-on therapy in subjects with type 2 diabetes inadequately controlled with metformin plus a sulfonylurea agent.
4 In an effort to determine the long-term tolerability of saxagliptin in older patients with T2DM, data from patients aged ≥65 years and <65 years who participated in trials of saxagliptin 5 mg as add-on to metformin, a thiazolidinedione, or glyburide were analyzed.
Data from three Phase 3 studies were analysed, in which: (Study 1) canagliflozin 100 and 300 mg were compared with placebo as monotherapy for 26 weeks; (Study 2) canagliflozin 100 and 300 mg were compared with placebo as add-on to metformin + sulfonylurea for 26 weeks; or (Study 3) canagliflozin 300 mg was compared with sitagliptin 100 mg as add-on to metformin + sulfonylurea for 52 weeks.
−2.31% for saxagliptin/metformin 5/500 mg* −2.33% for saxagliptin/metformin 10/500 mg* −1.55% for saxagliptin 10 mg −1.79% for metformin 500 mg (* P < 0.0001 versus metformin and saxagliptin monotherapies) saxagliptin 5 mg once daily as add on therapy to previously taken metformin sitagliptin 100 mg once daily as add-on therapy to previously taken metformin.
