LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3% were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3%) patients with prior CVD and 1,748 (18.7%) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.

DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. The primary end point was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Patients with T2D at high risk of cardiovascular complications were randomized 1:1 to receive either IDeg or IGlar, each added to background therapies. This trial was designed to demonstrate statistical noninferiority of IDeg vs IGlar for the primary end point. DEVOTE enrolled 7,637 patients between October 2013 and November 2014 at 436 sites in 20 countries. Of these, 6,506 patients had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors. DEVOTE was designed to provide conclusive evidence regarding the cardiovascular safety of IDeg relative to IGlar in a high-risk population of patients with T2D.

Patient compliance with diet, lifestyle and medication regimens is an essential part of the management of type 2 diabetes mellitus. Issues and barriers relating to patient compliance were investigated in group discussions with a total of 123 patients with type 2 diabetes in four European countries and the USA. Patients were found to be well motivated to comply with advice on diet and lifestyle, but many felt they had received insufficient information about their disease and prescribed treatments. In addition, patients often felt that the reasons behind the lifestyle and dietary advice had not been adequately explained, and that dietary advice was vague. Consequently, patients' understanding of the reasons for the changes they believed they had to make was often poor, and they found some lifestyle changes difficult to make. Eating at regular times, not missing meals, reducing alcohol intake or favourite foods, and taking tablets at the same time each day without fail were all directives where a degree of non‐compliance was admitted. There was confusion between diet and lifestyle changes aimed at improving metabolic control and risk profile, and those required to offset the risk of hypoglycaemia inherent in some antidiabetic therapies (e.g. long‐acting sulphonylureas), such as eating meals at set times. It is unfortunate that, by imposing additional diet and lifestyle restrictions, such hypoglycaemic therapies compromise patients' lifestyles and divert their energy and commitments from genuinely beneficial behaviour changes. Copyright © 2002 John Wiley & Sons, Ltd.

OBJECTIVE— This double-blind randomized placebo-controlled parallel group study assessed the efficacy and safety (with particular regard to body weight and hypoglycemia) of repaglinide when used in a flexible mealtime dosing regimen in a situation close to everyday clinical practice. RESEARCH DESIGN AND METHODS— A total of 408 patients with type 2 diabetes considered poorly controlled by diet, but without a history of previous antidiabetic medication, were randomized to receive 0.5 mg repaglinide at mealtimes (increased to 1 mg after 4 weeks depending on blood glucose response) or placebo for 16 weeks. Patients were free to choose a flexible meal pattern, adjusting the dosing schedule from two to four preprandial doses per day in accordance with a “one meal, one dose; no meal, no dose” principle. Additional snacks were not a requirement of the treatment schedule. RESULTS— Treatment with repaglinide significantly improved glycemic control with respect to baseline and placebo, reducing HbAlc by 1.14% from baseline and fasting plasma glucose by 1.8 mmol/l. Improvement in glycemic control was independent of the meal pattern adopted by patients, including those most commonly taking two or four meals daily, with no correlation between meal pattern and risk of hypoglycemia. The improvement in glycemic control was also independent of degree of obesity and age ≤65 or >65 years. There was no significant body weight increase in the repaglinide group. CONCLUSIONS— Mealtime dosing with repaglinide is effective in improving overall glycemic control in type 2 diabetic patients for which control is suboptimal using diet alone. Patients are able to vary their meal pattern from a conventional regimen of three meals daily without compromising control or increasing the risk of adverse events.

QoL scores of physical and functional domains as well as self-reported anaemia-related symptoms correlated well with haemoglobin level in chemotherapy-treated cancer patients.

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