Durability and tolerability of dapagliflozin over 52 weeks as add‐on to metformin and sulphonylurea in type 2 diabetes. Issue 11 (4th September 2015)

• Record Type: Journal Article
• Authors: Matthaei, S.; Bowering, K.; Rohwedder, K.; Sugg, J.; Parikh, S.; Johnsson, E.; on behalf of the Study 05 Group
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 11(2015:Nov.)
• Page Start: 1075
• Page End: 1084
• Publication Date: 2015-09-04
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12543
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12543-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12543-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12543-para-0001">To evaluate the safety and efficacy of dapagliflozin as add‐on therapy to metformin plus sulphonylurea over 52 weeks.</p> </sec> <sec id="dom12543-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12543-para-0002">Patients with type 2 diabetes mellitus (T2DM) using sulphonylurea and metformin received dapagliflozin 10 mg/day or placebo added to therapy for 52 weeks (24‐week randomized, double‐blind period plus 28‐week double‐blind extension).</p> </sec> <sec id="dom12543-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12543-para-0003">A total of 219 patients were randomized 1 : 1 to dapagliflozin or placebo. Over 52 weeks, glycated haemoglobin (HbA1c) and fasting plasma glucose levels showed greater improvement from baseline with dapagliflozin (−0.8% and −1.5 mmol/l) than with placebo (−0.1% and 0.6 mmol/l). More patients achieved HbA1c <7.0% with dapagliflozin (27.3%) than with placebo (11.3%) at 52 weeks. Dapagliflozin was associated with greater reductions in body weight and systolic blood pressure (−2.9 kg and −1.0 mmHg) compared with placebo (−1.0 kg and 1.1 mmHg). Greater increases in total, LDL and HDL cholesterol and decreases in triglycerides were observed with dapagliflozin (3.4, 4.8, 6.9 and −8.0%, respectively) versus placebo (1.4, 0.9, 0.6 and 2.9%, respectively). Fewer patients were rescued for failing to reach glycaemic targets with dapagliflozin (9.3%) than with placebo (44.4%). Adverse events and serious adverse events were similar between groups (dapagliflozin: 69.7 and 6.4%; placebo: 73.4 and 7.3%). More hypoglycaemic events were observed with dapagliflozin (15.6%) than with placebo (8.3%). Genital infections were reported in more patients in the dapagliflozin (10.1%) than in the placebo group (0.9%) and urinary tract infection frequency was similar in the two groups (10.1 and 11.0%).</p> </sec> <sec id="dom12543-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="dom12543-para-0004">Dapagliflozin as add‐on to metformin plus a sulphonylurea was well tolerated and improvement in glycaemic control was maintained over 52 weeks.</p> </sec> </abstract>