Background: Glucagon-like peptide 1 agonists differ in chemical structure, duration of action and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. Methods: We randomly assigned patients with type 2 diabetes and cardiovascular disease to the addition of once-weekly subcutaneous injection of albiglutide (30 mg to 50 mg) or matching placebo to standard care. We hypothesized that albiglutide would be noninferior to placebo for the primary outcome of first occurrence of cardiovascular death, myocardial infarction, or stroke. If noninferiority was confirmed by an upper limit of the 95% confidence interval for the hazard ratio of less than 1.30, closed-testing for superiority was prespecified. Findings: Overall, 9463 participants were followed for a median of 1.6 years. The primary composite outcome occurred in 338 of 4731 patients (7.1%; 4.6 events per 100 person-years) in the albiglutide group and in 428 of 4732 patients (9.0%; 5.9 events per 100 person-years) in the placebo group (hazard ratio, 0.78; 95% confidence interval [CI ], 0.68 to 0.90), indicating that albiglutide, was superior to placebo (P<0.0001 for noninferiority, P=0.0006 for superiority). The incidence of acute pancreatitis (albiglutide 10 patients and placebo 7 patients), pancreatic cancer (6 and 5), medullary thyroid carcinoma (0 and 0), and other serious adverse events did not differ significantly between the two groups. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. (Funded by GlaxoSmithKline; Harmony Outcomes ClinicalTrials.gov number, NCT02465515.) noninferiority; P = 0.06 for superiority). There seems to be variation in the results of existing trials with GLP-1 receptor agonists, which if correct, might reflect drug structure or duration of action, patients studied, duration of follow-up or other factors.

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Introduction Since insulin pens were first introduced in 1985, many advances have been made in pen needles (PNs). In this study we evaluated patient-reported outcomes of an investigational newly re-engineered 4 mm × 32G PN, the BD Nano™ 2nd Gen (also known by its “PRO” brand extension in many markets outside of the USA). In place of a conventional cylindrical posted hub, the investigational PN’s hub is contoured with an expanded surface area. The investigational PN also includes a redesigned inner shield that includes tactile ridges and a remodeled outer cover with improved proportions and attachment grips. Methods This was a multi-site, prospective, open-label, two-period crossover trial. Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6 mm in length for ≥ 4 months were eligible. Subjects using     31G PNs of a similar length were eligible after a 2-week wash-in period. Subjects were assigned to one of four groups, with each group using a commercially available PN to which the investigational PN was compared. Each of the two study periods were 15 days: one with the investigational PN and the other with a comparator PN. After completing both study periods, subjects compared experiences between the two PN types. A 150-mm comparative visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of >  − 10 mm or > 0 mm, respectively. Results At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined ( p < 0.05). Conclusions The investigational PN was rated as being overall preferred, more comfortable, less painful, and easier to use when compared to comparator PNs of similar gauge and length, in all groups combined. Clinical Trial Registration Clinicaltrials.gov (NCT03267264). Funding BD (Becton, Dickinson, and Company).

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