A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD‐ON). Issue 7 (11th February 2014)

• Record Type: Journal Article
• Authors: Mathieu, C.; Rodbard, H. W.; Cariou, B.; Handelsman, Y.; Philis‐Tsimikas, A.; Ocampo Francisco, A. M.; Rana, A.; Zinman, B.; on behalf of the BEGIN: VICTOZA ADD‐ON (NN1250‐3948) study group
• Is Part Of: Diabetes, obesity & metabolism. Volume 16:Issue 7(2014:Jul.)
• Page Start: 636
• Page End: 644
• Publication Date: 2014-02-11
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12262
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12262-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12262-sec-0001" sec-type="section"> <title>Aim</title> <p id="dom12262-para-0001">Two treatment strategies were compared in patients with type 2 diabetes (T2DM) on basal insulin requiring intensification: addition of once‐daily (OD) liraglutide (Lira) or OD insulin aspart (IAsp) with largest meal.</p> </sec> <sec id="dom12262-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12262-para-0002">Subjects completing 104 weeks (52‐week main trial BEGIN ONCE‐LONG + 52‐week extension) on insulin degludec (IDeg) OD + metformin with HbA1c ≥ 7.0% (≥53 mmol/mol) were randomized to IDeg+Lira [n = 88, mean HbA1c: 7.7% (61 mmol/mol)] or IDeg+IAsp (n = 89, mean HbA1c: 7.7%) for 26 weeks, continuing metformin. Subjects completing 104 weeks with HbA1c <7.0% continued IDeg + metformin in a third, non‐randomized arm (n = 236).</p> </sec> <sec id="dom12262-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12262-para-0003">IDeg+Lira reduced HbA1c (−0.74%‐points) significantly more than IDeg+IAsp (−0.39%‐points); estimated treatment difference (ETD) (IDeg+Lira−IDeg+IAsp) −0.32%‐points (95% CI −0.53; −0.12); p = 0.0024. More IDeg+Lira (49.4%) than IDeg+IAsp (7.2%) subjects achieved HbA1c <7.0% without confirmed hypoglycaemia [plasma glucose <3.1 mmol/l (<56 mg/dl) or severe hypoglycaemia) and without weight gain; estimated odds ratio (IDeg+Lira/IDeg+IAsp) 13.79 (95% CI 5.24; 36.28); p < 0.0001. IDeg+Lira subjects had significantly less confirmed and nocturnal confirmed hypoglycaemia, and significantly greater weight loss (−2.8 kg) versus IDeg+IAsp (+0.9 kg); ETD (IDeg+Lira−IDeg+IAsp) −3.75 kg (95% CI −4.70; −2.79); p < 0.0001. Other than more gastrointestinal side effects with IDeg+Lira, no safety differences occurred. Durability of IDeg was established in the non‐randomized arm, as mean HbA1c remained <7.0% [mean 6.5% (48 mmol/mol) at end‐of‐trial].</p> </sec> <sec id="dom12262-sec-0004" sec-type="section"> <title>Conclusions</title> <p id="dom12262-para-0004">IDeg+Lira improved long‐term glycaemic control, with weight loss and less hypoglycaemia versus adding a single daily dose of IAsp in patients with T2DM inadequately controlled with IDeg + metformin.</p> </sec> </abstract>