| Autor: |
Moses, R. G., Kalra, S., Brook, D., Sockler, J., Monyak, J., Visvanathan, J., Montanaro, M., Fisher, S. A. |
| Předmět: |
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| Zdroj: |
Diabetes, Obesity & Metabolism; May2014, Vol. 16 Issue 5, p443-450, 8p |
| Abstrakt: |
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/m2 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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