Linagliptin provides effective, well‐tolerated add‐on therapy to pre‐existing oral antidiabetic therapy over 1 year in Japanese patients with type 2 diabetes. Issue 9 (3rd May 2013)

• Record Type: Journal Article
• Authors: Inagaki, N.; Watada, H.; Murai, M.; Kagimura, T.; Gong, Y.; Patel, S.; Woerle, H.‐J.
• Is Part Of: Diabetes, obesity & metabolism. Volume 15:Issue 9(2013:Sep.)
• Page Start: 833
• Page End: 843
• Publication Date: 2013-05-03
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12110
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12110-sec-0001" sec-type="section"> <title>Aims</title> <p>To evaluate the long‐term safety and efficacy of linagliptin as add‐on therapy to one approved oral antidiabetic drug (OAD) in Japanese patients with type 2 diabetes mellitus and insufficient glycaemic control.</p> </sec> <sec id="dom12110-sec-0002" sec-type="section"> <title>Methods</title> <p>This 52‐week, multicentre, open‐label, parallel‐group study evaluated once‐daily linagliptin 5 mg as add‐on therapy to one OAD [biguanide, glinide, glitazone, sulphonylurea (SU) or α‐glucosidase inhibitors (A‐GI)] in 618 patients. After a 2‐week run‐in, patients on SU or A‐GI were randomized to either linagliptin (once daily, 5 mg) or metformin (twice or thrice daily, up to 2250 mg/day) as add‐on therapy. Patients receiving the other OADs received linagliptin add‐on therapy (non‐randomized).</p> </sec> <sec id="dom12110-sec-0003" sec-type="section"> <title>Results</title> <p>Adverse events were mostly mild or moderate, and rates were similar across all groups. Hypoglycaemic events were rare, except in the SU group. Overall, 26 (5.8%) hypoglycaemic events were reported in patients receiving linagliptin (non‐randomized). Hypoglycaemic events were similar for linagliptin and metformin added to A‐GI (1/61 vs. 2/61, respectively) or SU (17/124 vs. 10/63, respectively). Significant reductions in glycated haemoglobin (HbA1c) levels (between −0.7 and −0.9%) occurred throughout the study period for the background therapy groups that received linagliptin (baseline HbA1c 7.9–8.1%). The decline in HbA1c levels was indistinguishable between linagliptin and metformin groups when administered as add‐on therapy to A‐GI or SU.</p> </sec> <sec id="dom12110-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Once‐daily linagliptin showed safety and tolerability over 1 year and provided effective add‐on therapy leading to significant HbA1c reductions, similar to metformin, over 52 weeks in Japanese patients.</p> </sec> </abstract>