Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo‐controlled trial. Issue 11 (10th September 2015)

• Record Type: Journal Article
• Authors: Ahmann, A.; Rodbard, H. W.; Rosenstock, J.; Lahtela, J. T.; de Loredo, L.; Tornøe, K.; Boopalan, A.; Nauck, M. A.; on behalf of the NN2211‐3917 Study Group
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 11(2015:Nov.)
• Page Start: 1056
• Page End: 1064
• Publication Date: 2015-09-10
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12539
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12539-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12539-sec-0001" sec-type="section"> <title>Aim</title> <p id="dom12539-para-0001">To confirm the superiority, compared with placebo, of adding liraglutide to pre‐existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0–10.0% (53–86 mmol/mol)].</p> </sec> <sec id="dom12539-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12539-para-0002">In this 26‐week, double‐blind, parallel‐group study, conducted in clinics or hospitals, 451 subjects were randomized 1 : 1 to once‐daily liraglutide 1.8 mg (dose escalated from 0.6 and 1.2 mg/day, respectively, for 1 week each; n = 226) or placebo (n = 225) added to their pre‐existing basal insulin analogue (≥20 U/day) ± metformin (≥1500 mg/day). After randomization, insulin adjustments above the pre‐study dose were not allowed. The primary endpoint was HbA1c change.</p> </sec> <sec id="dom12539-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12539-para-0003">After 26 weeks, HbA1c decreased more with liraglutide [−1.3% (−14.2 mmol/mol)] than with placebo [−0.1% (−1.2 mmol/mol); p < 0.0001]. More subjects on liraglutide reached HbA1c targets: <7.0% (59% vs 14%; p < 0.0001) and ≤6.5% (43% vs 4%; p < 0.0001) using slightly less insulin (35.8 IU vs 40.1 IU). Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (−1.3 mmol/l), seven‐point glucose profiles (−1.6 mmol/l), body weight (−3.1 kg) and systolic blood pressure (−5.0 mmHg). Transient gastrointestinal adverse events (nausea: 22.2% vs 3.1%) and minor hypoglycaemia (18.2% vs 12.4%) were more frequent with liraglutide than placebo, and pulse increased (4.5 beats/min) compared with placebo. No severe hypoglycaemia or pancreatitis occurred.</p> </sec> <sec id="dom12539-sec-0004" sec-type="section"> <title>Conclusions</title> <p id="dom12539-para-0004">Adding liraglutide to a basal insulin analogue ± metformin significantly improved glycaemic control, body weight and systolic blood pressure compared with placebo. Typical gastrointestinal symptoms and minor hypoglycaemia were more frequent with liraglutide.</p> </sec> </abstract>