Publications by authors named "Luigi F Meneghini"

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of .

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Aims: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months.

Methods: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) 64 to 97 mmol/mol (8.0%-11.

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Diabetes continues to represent a substantial individual and societal burden for those affected by the disease and its complications in the United States, and especially for racial/ethnic minorities, the socioeconomically disadvantaged, and the underinsured. Although tools and strategies are now available to manage the condition and its associated comorbidities at the patient level, we continue to struggle to gain control of this health burden at the population health level. Most patients are not achieving desired clinical goals and thus continue to be exposed to preventable risks and complications.

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Introduction: iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and safety outcomes in participants who received the study-specified maximum dose (60 units/day) of iGlarLixi or iGlar vs. those who received < 60 units/day.

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Introduction: Type 2 diabetes (T2D) is characterized by worsening pancreatic β-cell function often requiring treatment escalation with oral antidiabetic drugs (OADs), glucagon-like peptide-1 and eventually insulin. Although there is much evidence available on the initiation of basal insulins, fewer studies have investigated the effects of switching from one basal insulin to another. This study aims to evaluate treatment persistence and hypoglycaemia in adult patients with T2D on prior basal insulin who were switched to insulin glargine 300 units/mL (Gla-300) or other basal insulins in a real-world setting.

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Aim: To compare the efficacy and safety of a glucagon-like peptide-1 receptor agonist (GLP1RA) plus basal insulin versus basal-bolus insulin treatment in patients with very uncontrolled type 2 diabetes.

Materials And Methods: The SIMPLE study was a 6-month pragmatic, randomized, open-label trial testing the effectiveness of two approaches to treat patients with type 2 diabetes and HbA1c ≥10%. We randomized patients to detemir plus liraglutide or detemir plus aspart (before each meal).

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Aims: To describe in a real-world setting the achievement of physician-selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement.

Materials And Methods: A 12-week, prospective, single-arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonists.

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Aims: To examine the association of baseline patient characteristics with study outcomes in people with type 2 diabetes receiving insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100), over a 6-month period.

Methods: A post hoc patient-level meta-analysis using data from three multicenter, randomized, open-label, parallel-group, phase 3a studies of similar design, in people previously receiving either basal and prandial insulin, basal insulin + oral antihyperglycemic drugs, or no prior insulin (EDITION 1, 2 and 3, respectively). The endpoints, glycated hemoglobin (HbA), hypoglycemia, body weight change, and insulin dose were investigated by subgroups: age (< 65 and ≥ 65 years), body mass index (BMI; < 30 and ≥ 30 kg/m), age at onset (< 40, 40-50, and > 50 years), and diabetes duration (< 10 and ≥ 10 years).

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Aims: To evaluate the clinical and patient-reported outcomes and healthcare utilization and costs associated with patient-reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin.

Materials And Methods: This was an observational, cross-sectional, survey-based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid-acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.

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Aim: To evaluate the effect of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) on clinical and economic outcomes in patients with type 2 diabetes (T2D).

Methods: We conducted a retrospective observational claims study using IMPACT (Impact National Managed Care Benchmark Database) in adult patients with T2D who initiated basal insulin between January 1, 2005 and December 31, 2012, with or without OADs, who remained uncontrolled (glycated haemoglobin [HbA1c] ≥7.0%).

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Background: To determine whether previously reported reductions in hypoglycemia associated with insulin glargine 300 U/mL (Gla-300) compared with insulin glargine 100 U/mL (Gla-100) are impacted by patient risk category in type 2 diabetes (T2D), clinical performance measures based on the Healthcare Effectiveness Data and Information Set (HEDIS) were applied to patient-level data from the EDITION 2 and EDITION 3 clinical trials that compared Gla-300 and Gla-100.

Methods: In this post hoc analysis, patients were stratified as low risk (LR) if patients were <65 years old with no comorbidities derived from HEDIS (HbA1c target <7.0% [53 mmol/mol]), or as high risk (HR) if patients were either ≥65 years old or had one or more HEDIS-defined comorbidities (HbA1c target <8.

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Objective: This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia.

Methods: Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA). Inclusion criteria include a diagnosis of T2D, age ≥18 years, and glycated hemoglobin (HbA1c) between 8.

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Objective: The build-up in insulin levels following repeated injection of prandial insulin at close intervals--referred to as insulin stacking--can increase the risk of hypoglycemia. With the development of basal insulins with a half-life > 24 hours and a duration of action > 40 hours, clinicians may be concerned about stacking when these long-acting formulations are administered once daily. The objective of this review is to clarify the difference between inappropriate insulin stacking when shorter-acting insulin formulations are repeatedly used to correct hyperglycemia and the appropriate accumulation of long-acting insulin formulations dosed to steady-state pharmacokinetic (PK) profiles.

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The progressive nature of type 2 diabetes (T2D) requires practitioners to periodically evaluate patients and intensify therapy when glycemic targets become unattainable with their current treatment regimen. Traditional first- and second-line antidiabetic agents such as metformin and the sulfonylureas do not prevent the characteristic decline in beta-cell function associated with T2D; insulin replacement therapy can therefore quickly become a necessity in some patients. Basal insulin initiation provides an excellent platform to which rapid-acting prandial insulin doses can easily be added, potentially in a stepwise manner, as disease progresses.

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Objective: The SOLVE study investigated the initiation of basal insulin in patients with type 2 diabetes on oral antidiabetic (OAD) treatment and outcomes in patients with varying levels of glycemic control at baseline.

Methods: This was an observational cohort study conducted in 10 countries using insulin detemir. Data were collected at 3 clinic visits (baseline, 12-week interim, and 24-week final visit).

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Family physicians are responsible for diagnosing and treating the majority of people with type 2 diabetes mellitus and co-morbid depression. As a result of the impact of co-morbid depression on patient self-care and treatment outcomes, screening for depression in the context of a structured approach to case management and patient follow up is recommended in people with diabetes and cardiovascular disease. This review summarizes the need for improved recognition and treatment of depression in diabetes; and makes expert recommendations with regard to integrating screening tools and therapies into a busy family or general medical practice setting.

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Insulin therapy provides effective glycemic control in patients with diabetes who have deficient beta-cell function and insulin secretion. Subjects with type 2 diabetes not adequately controlled on oral agents or incretin therapies can initiate basal insulin replacement to correct fasting hyperglycemia. While all basal insulin preparations have similar efficacy in lowering fasting plasma glucose and improving A1C, the newer basal insulin analogs are associated with a lower risk of hypoglycemia than NPH insulin.

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The prevalence of diabetes, a chronic disease that currently poses a significant health burden in both developed and developing countries, is expected to increase significantly over the foreseeable future. In Type 1 diabetes, insulin replacement is absolutely imperative; in Type 2 diabetes, many patients will eventually require insulin replacement therapy to compensate for progressive β-cell failure and maintain blood glucose control. Even though currently available insulin analog preparations more closely mimic physiologic insulin needs when compared with neutral protamine Hagedorn insulin, many patients with diabetes still experience unacceptable glycemic control, in part owing to limitations in insulin therapy, such as hypoglycemia risk, weight gain and the need for patients to adjust their lifestyle to their insulin therapy.

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There is a need for biomarkers to monitor the development and progression of type 1 DM. We analyzed mRNA expression levels for granzyme B, perforin, fas ligand, TNF-α, IFN-γ, Foxp3, IL-10, TGF-β, IL-4, IL-6, IL-17, Activation-induced cytidine deaminase (AID) and Immunoglobulin G gamma chain (IgG) genes in peripheral blood of at-risk, new-onset and long-term type 1 DM , and healthy controls. The majority of the genes were suppressed in long-term type 1 DM compared to controls and new-onset patients.

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Objective: Insulin degludec (IDeg) is a basal insulin that forms soluble multihexamers after subcutaneous injection, resulting in an ultra-long action profile. We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1 diabetes.

Research Design And Methods: In this 16-week, randomized, open-label trial, participants (mean: 45.

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Objective: To compare glycemic control with add-on insulin glargine versus pioglitazone treatment in patients with type 2 diabetes.

Methods: This 48-week, multicenter, parallel-group, open-label study randomized 389 adults with poorly controlled type 2 diabetes (glycated hemoglobin A1c [A1C], 8.0% to 12.

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Glycemic control before, during, and after surgery reduces the risk of infectious complications; in critically ill surgical patients, intensive glycemic control may reduce mortality as well. The preoperative assessment is important in determining risk status and determining optimal management to avoid clinically significant hyper- or hypoglycemia. While patients with type 1 diabetes should receive insulin replacement at all times, regardless of nutritional status, those with type 2 diabetes may need to stop oral medications prior to surgery and might require insulin therapy to maintain blood glucose control.

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