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A randomized controlled trial of the efficacy and safety of saxagliptin as add‐on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea
Author(s) -
Moses R. G.,
Kalra S.,
Brook D.,
Sockler J.,
Monyak J.,
Visvanathan J.,
Montanaro M.,
Fisher S. A.
Publication year - 2014
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12234
Subject(s) - saxagliptin , metformin , medicine , type 2 diabetes , randomized controlled trial , diabetes mellitus , pharmacology , endocrinology , sitagliptin
Aims To evaluate the efficacy and safety of saxagliptin as add‐on therapy in adults with type 2 diabetes with inadequate glycaemic control on metformin plus a sulphonylurea. Methods In this 24‐week, multicentre, randomized, parallel‐group, double‐blind study, outpatients aged ≥18 years with type 2 diabetes, body mass index ≤40 kg/m 2 and inadequate glycaemic control, received saxagliptin 5 mg or placebo once‐daily added to background medication consisting of a stable maximum tolerated dose of metformin plus a sulphonylurea. The primary end point was change in glycated haemoglobin ( HbA1c ) from baseline to week 24. Safety and tolerability assessments included adverse events ( AEs ), hypoglycaemia and body weight. Results A total of 257 patients were randomized, treated and included in the safety analysis (saxagliptin, n = 129; placebo, n = 128); 255 were included in the efficacy analysis (saxagliptin, n = 127; placebo, n = 128). HbA1c reduction was greater with saxagliptin versus placebo [between‐group difference in adjusted mean change from baseline, −0.66%; 95% confidence interval ( CI ), −0.86 to −0.47 (7 mmol/mol, −9.4 to −5.1); p < 0.0001]. The proportion of patients with ≥1 AE was 62.8% with saxagliptin and 71.7% with placebo. In the saxagliptin and placebo groups, rates of reported hypoglycaemia were 10.1 and 6.3%, respectively, and rates of confirmed hypoglycaemia (symptoms + glucose < 2.8 mmol/l) were 1.6 and 0%. Mean change in body weight was 0.2 kg for saxagliptin and −0.6 kg for placebo (p = 0.0272). Conclusion Addition of saxagliptin 5 mg/day in patients inadequately controlled on metformin and sulphonylurea effectively improved glycaemic control and was well tolerated.