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- Title
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).
- Authors
Mathieu, C.; Rodbard, H. W.; Cariou, B.; Handelsman, Y.; Philis‐Tsimikas, A.; Ocampo Francisco, A. M.; Rana, A.; Zinman, B.
- Abstract
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.
- Subjects
TYPE 2 diabetes; INSULIN aspart; METFORMIN; COMPARISON (Philosophy); DOSE-effect relationship in pharmacology; HYPOGLYCEMIA; WEIGHT loss; RANDOMIZED response; THERAPEUTICS
- Publication
Diabetes, Obesity & Metabolism, 2014, Vol 16, Issue 7, p636
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12262