Inhaled technosphere insulin: a novel delivery system and formulation for the treatment of types 1 and 2 diabetes mellitus.

Complications from uncontrolled diabetes mellitus were reduced significantly with the introduction of insulin more than 90 years ago. Despite the proven benefits of normal glycemic levels, patients are deterred by the inconvenience and perceived pain related to multiple daily subcutaneous insulin injections. Inhaled insulin was first approved by the U.S. Food and Drug Administration (FDA) in 2006, but because profit margins did not achieve expectations, the drug manufacturer discontinued sales 2 years later. The second-generation inhaled insulin, developed with Technosphere technology, received FDA approval in 2014. The pharmacology, pharmacokinetics, drug interactions, clinical safety and efficacy, patient satisfaction, dosage and administration, warnings, precautions, contraindications, adverse effects, and place in therapy of inhaled Technosphere insulin are reviewed in this article.

Management of type 2 diabetes mellitus in self-motivated patients: optimized diet, exercise, and medication for weight loss and cardiometabolic fitness.

Type 2 diabetes mellitus (T2DM) is a growing public health problem with significant lifetime health care costs. The majority of Americans do not achieve minimal targets for exercise, and individuals with T2DM typically engage in less exercise than the general adult population. However, those patients with T2DM who are sufficiently self-motivated to manage their condition have the potential to reverse diabetes and prevent its complications through behavioral and pharmacologic interventions. Marked improvements are possible through increased awareness and selection of healthy eating options, a willingness to incorporate vigorous exercise into their lifestyle, and the use of newer medications that essentially eliminate the risk of hypoglycemia while facilitating weight loss and the achievement of ideal glucose targets. For self-motivated patients, daily aerobic activity of 45 to 60 minutes per day may be a suitable target. For those who have cardiovascular clearance, high-intensity interval training accomplishes high levels of cardiometabolic fitness with shorter training periods by alternating moderate and intense exertion. Suitable medications that have a low risk of hypoglycemia during exercise include metformin, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and sodium-glucose linked transporter-2 inhibitors. Specific daily caloric goals and incorporation of a mainly plant-based diet should be considered as a primary target for diabetes management. Self-management is important to achieving diabetes treatment goals, and mobile applications can be useful tools to support lifestyle changes in patients with T2DM.

Physiologic and weight-focused treatment strategies for managing type 2 diabetes mellitus: the metformin, glucagon-like peptide-1 receptor agonist, and insulin (MGI) approach.

The prevalence of type 2 diabetes mellitus (T2DM) is rising in association with an increase in obesity rates. Current treatment options for patients with T2DM include lifestyle modifications and numerous antidiabetic medications. Despite the availability of effective and well-tolerated treatments, many patients do not achieve recommended glycemic targets. Lack of efficacy is complicated by the wide range of available agents and little specificity in treatment guidelines, thus challenging clinicians to understand the relative benefits and risks of individual options for each patient. In this article, lifestyle intervention strategies and current antidiabetic agents are evaluated for their efficacy, safety, and weight-loss potential. Because of the heterogeneous and progressive nature of T2DM, physicians should advocate approaches that emphasize weight management, limit the risk of hypoglycemia and adverse events, and focus on the core pathophysiologic defects in patients with T2DM. A healthy, plant-based diet that is low in saturated fat and refined carbohydrates but high in whole grains, vegetables, legumes, and fruits, coupled with resistance and aerobic exercise regimens, are recommended for patients with T2DM. When necessary, drug intervention, described in this article as the MGI (metformin, glucagon-like peptide-1 receptor agonist, and insulin) approach, should begin with metformin and progress to the early addition of glucagon-like peptide-1 receptor agonists because of their weight loss potential and ability to target multiple pathophysiologic defects in patients with T2DM. For most patients, treatments that induce weight gain and hypoglycemia should be avoided. Long-acting insulin should be initiated if glycemic control is not achieved with metformin and glucagon-like peptide-1 receptor agonist combination therapy, focusing on long-acting insulin analogs that induce the least weight gain and have the lowest hypoglycemic risk. Ultimately, a patient-centered treatment approach that addresses the core pathologies of T2DM and obesity will not only increase overall efficacy and the likelihood that a patient adheres to treatment, but may also improve a patient's mental well-being and quality of life.

Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning.

OBJECTIVE: FlexTouch * (FT) is a new prefilled insulin pen with no push-button extension at any set dose and a low activation force that is designed to improve ease of use and insulin administration. This paper reports the results of two usability studies assessing perceptions of FT compared with KwikPen † (KP)and SoloStar ‡ (SS) among healthcare professionals (HCPs; both physicians and nurses) and people with diabetes (both insulin pen-experienced and insulin pen-naïve). RESEARCH DESIGN AND METHODS: Participants were randomly assigned to start with FT or KP in one study and FT or SS in the other. Participants performed injections at different doses (20, 40 and 60 International Units [IU] in the FT vs. KP study or 20, 40 and 80 IU in the FT vs. SS study) into a foam cushion before answering questions on ease of use, teaching and learning, confidence and preference. RESULTS: A total of 59 people with diabetes and 61 HCPs took part in the FT vs. SS study, and 79 people with diabetes and 81 HCPs took part in the FT vs. KP study. Considerably more patients and HCPs rated FT as very/fairly easy to inject with than KP or SS, particularly at the maximum dose (≥80% vs. ≤38% and ≤23%, respectively), and more were very/rather confident in the ability to manage daily insulin injections with FT than KP or SS. Overall, FT was rated significantly higher for ease of teaching and learning to use than KP or SS (all p < 0.001 vs. FT), and was preferred for teaching and learning compared with KP or SS (≥39% vs. ≤4% and ≤6%, respectively). More patients and HCPs would recommend FT (≥95%) than KP (≤72%) or SS (≤71%). The same pattern was generally seen across physicians, nurses, insulin pen-experienced and pen-naïve participants. CONCLUSIONS: The findings suggest that devices such as FT are easy to use and can be prescribed with relatively few training needs, which may improve ease of insulin initiation, increase pen use, and ultimately improve treatment adherence. A limitation of the usability questionnaire used in this study is that it did not assess the factors that influence preference. Further analyses could be conducted to determine the factors that appeal to different users.

Ease of use and preference of a new versus widely available prefilled insulin pen assessed by people with diabetes, physicians and nurses.

OBJECTIVE: FlexTouch® (FT; Novo Nordisk A/S, Bagsvaerd, Denmark) is a new prefilled insulin pen that has no push-button extension and low injection force. This multi-centre, crossover usability study evaluated the perceptions of, and preference for, FT versus another widely used prefilled pen, SoloStar® (SS; Sanofi, Paris, France), by people with diabetes and healthcare professionals. RESEARCH DESIGN AND METHODS: Following instruction, participants performed injections into a foam cushion, randomly alternating between doses of 20, 40 and 80 international units (IU). Participants then answered questions on usability and preference. RESULTS: In all, 59 people with diabetes and 61 healthcare professionals (30 physicians and 31 nurses) took part. Overall, significantly more respondents preferred to use FT than SS (83 vs 10%, respectively), found FT easier to use (83 vs 9%) and would recommend FT to others (83 vs 8%; p < 0.001 for all). More respondents found it 'very/fairly easy' to reach the push-button and to inject 20, 40 and 80 IU with FT (93, 90 and 88% to inject, respectively) than with SS (73, 43 and 15% to inject, respectively; p < 0.001 for all). Most respondents chose FT as giving them the most confidence in correct and complete insulin delivery (76 vs 6%; p < 0.001) and considerably more were 'very/rather confident' in managing their daily insulin injections with FT than with SS (88 vs 58%). CONCLUSIONS: Most participants rated FT as easier to use and to inject with, were more confident in its accuracy of insulin delivery and preferred it to SS.

Partnering with patients to improve therapeutic outcomes: incretin-based therapy for type 2 diabetes.

The prevalence of type 2 diabetes mellitus has reached epidemic proportions. Current treatment options for patients with diabetes include lifestyle modifications (eg, diet and exercise) along with pharmacotherapy (eg, oral antidiabetic drugs [OADs], incretin-based therapies, and insulin). Despite the availability of effective and safe treatments, many patients do not achieve recommended glycemic targets, thereby increasing their risk of long-term complications. Given the progressive nature of diabetes and the need for extensive patient management, it is important that physicians and patients develop a partnership to achieve therapeutic goals. At diagnosis, the diabetes care team, led by the patient, should evaluate all aspects of management, including appropriate treatment options that are suited to the patient's quality of life, convenience, and therapeutic goals. Treatment should also consider the patient's comorbidities, including hypertension and obesity. Management of early type 2 diabetes should include OADs and incretin-based therapies, and preference should be given to agents that do not cause either hypoglycemia or weight gain. A basal insulin should be initiated if glycemic control is not achieved with >or= 1 agents or if presenting glucose control is poor. Irrespective of pharmacotherapy, all patients should be encouraged to maintain a healthy diet and exercise regimen. Patients also need to become active participants in disease management by monitoring blood glucose, complying with medication, adhering to lifestyle modifications, and setting weight loss goals when appropriate. This article emphasizes the need for physicians and other health care providers to partner with patients to achieve therapeutic goals and presents a novel, multifaceted approach toward improving the management of diabetes in a clinical practice setting.

Defining the role of incretin mimetic therapy in the management of type 2 diabetes.

Diabetes mellitus affects 21 million Americans; an additional 41 million individuals in this country have impaired glucose tolerance. These individuals are at high risk for developing not only diabetes, but eventually dying from the cardiovascular complications associated with chronic exposure to hyperglycemia. Not only do patients with diabetes carry a 1.5- to 4.5-fold increased risk of cardiovascular mortality, any microvascular complications they develop such as retinopathy, neuropathy, and nephropathy can have a profoundly negative effect on their quality of life. Even mild hyperglycemia is associated with macrovascular disease. Similarly, hyperglycemia that occurs concurrently during an acute myocardial infarction or stroke is associated with worse outcomes. Therefore, evidence suggests that both chronic and acute hyperglycemia lead to higher morbidity and mortality. As people age, their 2-hour postchallenge blood glucose level typically increases, often independent of their fasting glucose level. At diagnosis, 25% of patients with type 2 diabetes have normal fasting glucose levels. The incidence of isolated impaired glucose tolerance is approximately 3 times greater than isolated impaired fasting glucose. Therefore, most patients with asymptomatic diabetes have isolated postchallenge hyperglycemia. A growing body of literature supports targeting postprandial hyperglycemia to lower glycosylated hemoglobin (A1C) levels and reduce microvascular and macrovascular complications associated with chronic hyperglycemia. This article will evaluate a typical patient case and strategies employed by the patient and health care provider.