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)

Aim 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. Methods Subjects completing 104 weeks (52‐week main trial BEGIN ONCE‐LONG + 52‐...

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Bibliographic Details
Published in:	Diabetes, obesity & metabolism Vol. 16; no. 7; pp. 636 - 644
Main Authors:	Mathieu, C., Rodbard, H. W., Cariou, B., Handelsman, Y., Philis-Tsimikas, A., Ocampo Francisco, A. M., Rana, A., Zinman, B.
Format:	Journal Article
Language:	English
Published:	Oxford, UK Blackwell Publishing Ltd 01-07-2014 Wiley Subscription Services, Inc
Subjects:	Antidiabetics Blood Glucose - drug effects Body Mass Index Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Drug Administration Schedule Drug Combinations Drug Therapy, Combination Female Glucagon-Like Peptide 1 - administration & dosage Glucagon-Like Peptide 1 - analogs & derivatives Glucagon-Like Peptide 1 - therapeutic use Humans Hypoglycemia Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - therapeutic use Insulin insulin analogues Insulin Aspart - administration & dosage Insulin Aspart - therapeutic use Insulin, Long-Acting - administration & dosage Insulin, Long-Acting - therapeutic use Liraglutide Male Metformin Metformin - therapeutic use Middle Aged Treatment Outcome type 2 diabetes Weight Weight Loss - drug effects insulin analogues type 2 diabetes
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Summary:	Aim 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. Methods 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). Results 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]. Conclusions 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.
Bibliography:	ark:/67375/WNG-8XQSKMVZ-M ArticleID:DOM12262 istex:C10794EF21322BEB9A72DDFE963DADBD7853EC16 Novo Nordisk A/S Appendix. Inclusion and exclusion criteria; Dosing/titration information; Trial design and participant flow; Supplemental adverse event data; List of trial investigators. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23
ISSN:	1462-8902 1463-1326
DOI:	10.1111/dom.12262