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This trial assessed the efficacy and safety of liraglutide as compared with placebo, added to metformin (with or without basal insulin treatment), in children and adolescents with type 2 diabetes. The addition of liraglutide was efficacious and relatively safe in improving glycemic control over 52 weeks.

Introduction The LEADER trial was a cardiovascular (CV) outcomes trial in patients with type 2 diabetes at high CV risk that compared liraglutide ( n  = 4668) with placebo ( n  = 4672) using a primary composite endpoint of 3-point major adverse CV events. The objective of this post hoc analysis was to investigate glycaemic outcomes across both treatment groups. Methods Glycated haemoglobin (HbA 1c ) was measured at randomisation, month 3, month 6 and every 6 months thereafter. Cox regression was used to analyse time to a composite endpoint of glycaemic deterioration, defined as a specified change in HbA 1c or a substantial intensification of insulin or oral antihyperglycaemic drug (OAD). The individual components of the composite were also analysed. Results Baseline characteristics, including insulin and OAD use, were balanced between treatment groups. HbA 1c decreased from baseline in both groups, but the reduction was greater with liraglutide [estimated treatment difference at month 36: − 0.40%; 95% confidence interval (CI) − 0.45, − 0.34] despite the addition of more OADs and higher insulin use in the placebo group. Fewer of the patients treated with liraglutide ( n  = 3202, 68.6%) experienced glycaemic deterioration compared with those administered the placebo ( n  = 3988, 85.4%; average hazard ratio: 0.50; 95% CI 0.48, 0.53; p  < 0.001). Analysis of the individual components showed similar results (both p  < 0.001). Conclusions Type 2 diabetes patients at high risk of CV events who were treated with liraglutide achieved greater reductions in HbA 1c , had a lower risk of hypoglycaemia and presented less glycaemic deterioration than similar patients who received the placebo. Nonetheless, progressive loss of glycaemic control occurred in both groups. Trial Registration ClinicalTrials.gov, NCT01179048. Funding Novo Nordisk. Plain Language Summary Plain language summary available for this article.

Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n=167) or saline (n=170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p=0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered. Conclusion In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI ≥10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment.