AimsTo evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in elderly patients (aged ≥65 years) with type 2 diabetes (T2D) in six phase III clinical trials.MethodsPatients were grouped into two age groups: ≥65 and <65 years. Pooled analysis for glycated haemoglobin (HbA1c) change from baseline, percentage of patients achieving HbA1c targets, and gastrointestinal tolerability were evaluated at 26 weeks for each dulaglutide dose. Change in weight from baseline and rates of hypoglycaemia were evaluated for each individual study.ResultsA total of 958 of 5171 (18.5%) patients were aged ≥65 years. The reductions in HbA1c were similar between age groups for dulaglutide 1.5 mg‐treated patients {least squares [LS] mean for patients aged ≥65 years: −1.24 [95% confidence interval (CI) −1.36, −1.12] and for patients aged <65 years: −1.29 [95% CI −1.38, −1.20]} and for dulaglutide 0.75 mg‐treated patients [LS mean for patients aged ≥65 years: −1.16 (95% CI −1.29, −1.03) and for patients aged <65 years: −1.10 (95% CI −1.19, −1.01)] at 26 weeks. The percentages of patients who achieved HbA1c targets of <7, <8 or <9% were also similar in the two groups with both dulaglutide doses. Patients aged ≥65 years had similar weight change to patients aged <65 years. Severe hypoglycaemic events were infrequent. A similar incidence of gastrointestinal adverse events was observed in each age group with both dulaglutide doses.ConclusionBoth dulaglutide doses were well tolerated, with similar efficacy in patients with T2D aged ≥65 years to those aged <65 years. Dulaglutide can be considered a safe and effective treatment option for use in older adults.

We evaluated patient-reported outcome (PRO) measures from the Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes (AWARD) clinical trial programme for dulaglutide (1.5 mg and 0.75 mg) in patients with type 2 diabetes (T2D). The Impact of Weight on Self-Perception (IW-SP), Impact of Weight on Ability to Perform Physical Activities of Daily Living (APPADL), Impact of Weight on Quality of Life-Lite, EQ-5D, Diabetes Treatment Satisfaction Questionnaire (DTSQ), Diabetes Symptom Checklist-Revised and Adult Low Blood Sugar Survey were administered and analysed for changes from baseline in one or more AWARD studies. Significant within-group changes from baseline to the primary time point were observed for several PRO measures across all studies. Compared with insulin glargine, significantly greater improvements in the IW-SP score were observed with dulaglutide 1.5 mg and with both dulaglutide doses in the APPADL score. Both dulaglutide doses resulted in significantly greater improvement in DTSQ scores (all subscales) compared with exenatide. Dulaglutide 1.5 mg also resulted in significantly greater improvement on the DTSQ hyperglycaemia subscale compared with metformin. Overall, these PRO results suggest that dulaglutide is beneficial in the treatment of T2D.

Some therapies for diabetes increase the risk of hypoglycaemia, in particular all insulins and insulin secretagogues, including the glinides and sulfonylureas. Hypoglycaemia remains a major limiting factor to successful glycaemic management, despite the availability of prevention options such as insulin analogues, continuous glucose monitoring, insulin pumps, and dogs that have been trained to detect hypoglycaemia. Non‐severe (self‐treated) and severe (requiring assistance for recovery) hypoglycaemia rates are higher in people with type 1 diabetes, but those with insulin‐treated type 2 diabetes are also at risk. Education and regular review are essential between people with diabetes and their caregivers and healthcare professionals about symptoms, prevention and treatment. Awareness of the potential dangers of hypoglycaemia is fundamental to the optimal management of diabetes. When therapy is intensified to achieve glycaemic targets, it is important that people at risk of severe hypoglycaemia, and particularly their caregivers, have ready access to effective treatment for hypoglycaemia emergencies. The current and potential formulations of glucagon available for treatment of severe hypoglycaemia are reviewed.

Background Most conventional, oral, preventive treatments for migraine are non-specific and ~50% of patients discontinue them within six months. In 2018, the Food and Drug Administration approved three preventive migraine treatments: monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway implicated in migraine; galcanezumab and fremanezumab which target CGRP ligand; and erenumab which targets CGRP receptor. Real-world treatment patterns for CGRP mAb are limited. Purpose To compare real-world treatment patterns for CGRP mAb, specifically galcanezumab versus standard-of-care (SOC) migraine preventive treatments. Patients and methods This retrospective, observational study included 12-month baseline and 6- and 12-month follow-up analyses using IBM ® MarketScan ® databases. Patients identified were aged ≥18 years with ≥1 claim (first claim=index) for CGRP mAb (erenumab, fremanezumab, or galcanezumab) or SOC preventives (eg, antiepileptics, beta-blockers, antidepressants, or onabotulinumtoxinA) as index drugs between May/01/2018 and June/30/2019. Propensity score matching was used to address confounding by observed covariates. Outcomes analyzed included proportion of days covered (PDC), persistence (≤60-day gap), and first non-index drug switch. Descriptive, chi-square (categorical), and t -test (continuous) analyses were conducted. Results The study included 3082 (CGRP mAb versus SOC) and 421 (galcanezumab versus SOC) matched patient pairs with 12-month follow-up. Mean age across cohorts ranged 43.2–44.4 years (females: 85.7–88.6%). Compared with SOC, the CGRP mAb cohort had higher mean persistence (212.5 vs 131.9 days), adherence (PDC: 55.1% vs 35.2%), and more patients were adherent with PDC ≥80% (32.7% vs 18.7%) (all p <0.001). During 12-month follow-up, fewer patients discontinued CGRP mAb versus SOC (58.8% vs 77.6%, p <0.001). Galcanezumab versus SOC comparisons yielded similar results. In the CGRP mAb cohort, most switchers (28.3%) used galcanezumab as subsequent treatment. Largely similar results were observed for 6-month follow-up cohorts. Conclusion Patients on CGRP mAb and specifically galcanezumab showed higher adherence and persistence than patients on SOC migraine preventive treatments.

ObjectivesFear of hypoglycaemia (FoH) has been associated with suboptimal diabetes management and health outcomes. This study investigated factors associated with behavioural and emotional aspects of FoH among adults living with type 1 diabetes (T1D) mellitus.DesignCross-sectional study.SettingOnline survey hosted on T1D Exchange Glu, an online community for patients living with T1D mellitus.MeasuresThe Hypoglycaemia Fear Survey II-short form and the Hypoglycaemic Attitudes and Behaviour Scale were used to assess FoH. Multivariable regressions were performed on assessment scores.ResultsThe study included 494 participants (mean±SD age 43.9±12.2 years, duration of T1D mellitus 16.6±16.8 years, self-reported glycosylated hemoglobin (HbA1c) 6.9%±0.8% (52±9 mmol/mol)), 63% men, 89% on insulin pump, 25% experienced a severe hypoglycaemic event in the last 6 months. Multivariable regression analyses showed higher anxiety, depression severity and diabetes distress were independently associated with FoH (all p<0.01). Longer diabetes duration was associated with lower FoH (p<0.01). Past experience with severe hypoglycaemia was associated with higher worry of hypoglycaemia (p<0.01) but not avoidance behaviour (ns).ConclusionsThese results highlighted the multifaceted nature of FoH, which warrants further discussion between providers and patients to uncover drivers of and actions required to reduce FoH and improve patient care and outcomes.

Despite treatment advances leading to improved outcomes over the past 2 decades, cardiovascular (CV) disease (CVD) remains the leading cause of morbidity and mortality in people with diabetes. People with type 2 diabetes (T2D) have a 2-to 4-fold increased risk of CVD and CV death. Individuals with T2D have not seen the same improvements in CV morbidity and mortality as those without T2D. Given this, it is important to understand the CV impact of drugs used to treat T2D. In patients with T2D, glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown a reduction in HbA1c and body weight regardless of their differences in chemical structure and pharmacokinetic variables. Glycaemic efficacy, accompanied by the potential for weight reduction and a low risk of hypoglycaemia, has moved GLP-1RAs to the first treatment of choice following metformin monotherapy in the latest American Diabetes Association treatment guidelines. Additionally, all GLP-1RAs have shown CV safety and several have proven CV benefit. GLP-1RAs have been evaluated in cardiovascular outcomes trials (CVOTs) of varying sizes, designs and patient populations with differing reported effects on CV outcomes. The purpose of this article is to review the completed GLP-1RA CVOTs with special attention to how their design, size, patient populations and conduct may influence the interpretation of results.

Context Dulaglutide reduced major adverse cardiovascular events (MACE) in the REWIND Trial. Its efficacy and safety in older versus younger patients have not been explicitly analyzed. Objective To assess efficacy and safety of dulaglutide versus placebo in REWIND by age subgroups (≥65 and &lt;65 years). Design Post-hoc subgroup analysis of the REWIND trial. Setting Trial conducted at 371 sites in 24 countries. Patients Type 2 diabetes patients aged ≥50 years with established CV disease or multiple CV risk factors, and a wide range of glycemic control. Interventions Patients randomized (1:1) to dulaglutide 1.5 mg or placebo as add-on to country-specific standard of care. Main Outcome Measure: MACE (first occurrence of the composite of non-fatal myocardial infarction, non-fatal stroke, or death from CV or unknown causes) Results 5,256 randomized patients were ≥65 years (mean=71.0) and 4645 were &lt;65 years (mean=60.7). Baseline characteristics were similar in randomized treatment groups. Dulaglutide treatment showed a similar reduction in the incidence (11% vs 13%) of MACE in older versus younger patients. The rate of permanent study drug discontinuation, incidence of all-cause mortality, hospitalizations for heart failure, severe hypoglycemia, severe renal or urinary events, and serious gastrointestinal events were similar between randomized treatment groups within each age subgroup. The incidence rate of serious cardiac conduction disorders was numerically higher in the dulaglutide group compared to placebo within each age subgroup but the difference was not statistically significant. Conclusions Dulaglutide had similar efficacy and safety in REWIND in patients aged ≥65 years and those aged &lt;65 years.

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