Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release.

Objective: Treatment algorithms for type 2 diabetes recommend weight loss for disease management. The safety and efficacy of treatment with phentermine (PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized, double-blind, placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes.

Research Design And Methods: The OB-202/DM-230 Study was a 56-week phase 2 trial that randomized subjects to receive once-daily placebo or PHEN/TPM ER 15 mg/92 mg (15/92).

Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release.

OBJECTIVE To evaluate over 108 weeks the effect of phentermine and topiramate extended release (PHEN/TPM ER) treatment on progression to type 2 diabetes and/or cardiometabolic disease in subjects with prediabetes and/or metabolic syndrome (MetS) at baseline. RESEARCH DESIGN AND METHODS Subanalysis of a phase 3, randomized, placebo-controlled, double-blind study of overweight/obese subjects (BMI ≥27 to ≤45 kg/m(2)) with two or more comorbidities. Subjects were randomized to placebo, PHEN 7.

Effect of bromocriptine-QR (a quick-release formulation of bromocriptine mesylate) on major adverse cardiovascular events in type 2 diabetes subjects.

Background: Bromocriptine-QR (a quick-release formulation of bromocriptine mesylate), a dopamine D2 receptor agonist, is a US Food and Drug Administrration-approved treatment for type 2 diabetes mellitus (T2DM). A 3070-subject randomized trial demonstrated a significant, 40% reduction in relative risk among bromocriptine-QR-treated subjects in a prespecified composite cardiovascular (CV) end point that included ischemic-related (myocardial infarction and stroke) and nonischemic-related (hospitalization for unstable angina, congestive heart failure [CHF], or revascularization surgery) end points, but did not include cardiovascular death as a component of this composite. The present investigation was undertaken to more critically evaluate the impact of bromocriptine-QR on cardiovascular outcomes in this study subject population by (1) including CV death in the above-described original composite analysis and then stratifying this new analysis on the basis of multiple demographic subgroups and (2) analyzing the influence of this intervention on only the "hard" CV end points of myocardial infarction, stroke, and CV death (major adverse cardiovascular events [MACEs]).

Effect of bromocriptine-QR on glycemic control in subjects with uncontrolled hyperglycemia on one or two oral anti-diabetes agents.

Objective: To investigate the effect of Bromocriptine-QR on glycemic control in patients with type 2 diabetes whose glycemia is poorly controlled on one or two oral anti-diabetes agents.

Methods: Five hundred fifteen Type 2 Diabetes Mellitus (T2DM) subjects (ages 18 to 80 and average body mass index [BMI] of 32.7) with baseline HbA1c ≥ 7.

Individualized treatment of type 2 diabetes mellitus using noninsulin agents: clinical considerations for the primary care physician.

Background: The outcomes associated with some therapies may be potentially influenced by specific patient characteristics. Individualized therapy is an effort to achieve optimal health outcomes for a patient by selecting drugs known to be beneficial in persons with specific attributes or disease characteristics. With a broad literature base spanning several different medication classes, there is increasing potential for individualization of therapy in the treatment of type 2 diabetes mellitus.

TheV-Go insulin delivery device used in clinical practice: patient perception and retrospective analysis of glycemic control.

Objective: To describe patient perceptions regarding their experience and to report findings in a retrospective analysis of glycemic control in a cohort of patients who used the V-Go, a mechanical, 24-hour disposable, subcutaneous continuous insulin delivery device that delivers a preset basal infusion rate and on-demand insulin.

Methods: Patients used the V-Go and answered telephone surveys about their perception of device use. Corresponding clinical data were retrospectively collected before V-Go initiation, after 12 weeks of use, at the end of treatment, and 12 weeks after discontinuation.

Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver mealtime insulin for efficacy, preference, and quality of life in adults with diabetes: a randomized, crossover, multicenter study.

Objective: This study compared the efficacy, safety, device satisfaction, and quality of life (QOL) in people with diabetes using an insulin bolus-patch versus current devices (pen/syringe) to deliver mealtime insulin.

Research Design And Methods: Thirty-eight subjects with diabetes (26 with type 1 and 12 with type 2) were randomized to bolus-patch or current injection device (55% pen and 45% syringe) to deliver mealtime insulin in a multicenter, 6-week crossover study. Efficacy was assessed by equivalence in mean daily seven-point blood glucose (MDBG).

Insulin patch pumps: their development and future in closed-loop systems.

Steady progress is being made toward the development of a so-called "artificial pancreas," which may ultimately be a fully automated, closed-loop, glucose control system comprising a continuous glucose monitor, an insulin pump, and a controller. The controller will use individualized algorithms to direct delivery of insulin without user input. A major factor propelling artificial pancreas development is the substantial incidence of-and attendant patient, parental, and physician concerns about-hypoglycemia and extreme hyperglycemia associated with current means of insulin delivery for type 1 diabetes mellitus (T1DM).

A review of the response to oral antidiabetes agents in patients with type 2 diabetes.

In patients with type 2 diabetes, a progressive decline in glycemic control exacerbates the microvascular (retinopathy, neuropathy, and nephropathy) and macrovascular (cardiovascular disease, stroke, and peripheral arterial disease) complications associated with this disease. In a consensus statement, the American Diabetes Association and the European Association for the Study of Diabetes stated that the main goal of antidiabetes therapy is to achieve glycemic control, defined as a glycated hemoglobin of < 7%, although goals should be individualized to each patient, especially in patients at highest risk of cardiovascular disease events. However, because type 2 diabetes is a progressive disease, the response to oral antidiabetes (OAD) agents declines over time and the majority of patients are unable to maintain glycemic control, thus necessitating additional therapy.

Overview of the gliptin class (dipeptidyl peptidase-4 inhibitors) in clinical practice.

Dipeptidyl peptidase-4 inhibitors (DPP-4s), also commonly called gliptins, are a relatively new class of drugs for the treatment of type 2 diabetes. These agents work in a unique way to improve insulin secretion from the Beta-cells of the pancreas in response to an increase in blood sugar and simultaneously decrease glucagon output from the a-cells of the pancreas, which results in decreased hepatic glucose output. Specifi cally, gliptins decrease the breakdown of glucagon-like peptide-1 (GLP-1) such that the circulating levels reach the high normal physiologic GLP-1 range.

Assessment of long-term immunological and pulmonary safety of inhaled human insulin with up to 24 months of continuous therapy.

Background: This study was performed to characterize the long-term safety and efficacy of inhaled human insulin (EXU; Exubera * (insulin human [rDNA origin]) Inhalation Powder). * Pfizer Inc, New York, NY, USA.

Scope: Patients with type 1 or type 2 diabetes (N = 1290) who had successfully completed one of six controlled EXU open-label trials elected to receive open-label treatment with EXU for up to 3 years, after which they were randomized to discontinue EXU or to continue therapy for 6 months, then discontinue.

Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 1 diabetes: results of a 6-month, randomized, comparative trial.

Objective: The aim of this study was to determine whether premeal pulmonary delivery of rapid-acting, dry-powder insulin (Exubera) plus Ultralente could provide glycemic control comparable to a conventional insulin regimen in type 1 diabetes.

Research Design And Methods: Three hundred thirty-five subjects were randomly assigned to receive either premeal inhaled insulin plus bedtime Ultralente or two to three injections of regular and NPH insulin for 24 weeks. The primary end point was a change in HbA(1c).

Insulin therapy for reducing cardiovascular risk in patients with type 2 diabetes.

Twenty-four percent of the adult American population have the metabolic syndrome. Although somewhat counterintuitive, carefully regulated treatment with insulin has been shown to reduce insulin resistance and may also retard the development of cardiovascular disease by preventing chronic hyperglycemia, a condition that synergistically contributes to many proatherogenic pathways, including glycoxidation, the polyol pathway, advanced glycation end products, interference with normal metabolic pathways, and stimulation of protein kinase C-beta and proinflammatory pathways. This article describes some of the physiologic changes that occur when hyperglycemia and insulin resistance develop in patients with type 2 diabetes and discusses therapies, including insulin, that normalize glucose and reduce insulin resistance, thereby potentially reducing cardiovascular risk.

Optimizing insulin regimens in type 1 diabetes. How to help patients get control of their life.

The advances in insulin therapy in the past 5 years, including the introduction of insulin analogues, have made blood glucose control in patients with type 1 diabetes much more attainable. Diabetic patients can now achieve a better quality of life, including spontaneity and flexibility in lifestyle, than was possible with earlier insulin products. Here, Dr Bohannon discusses the latest improvements in acute and basal insulin therapy and presents three algorithms she has developed to help patients individualize their insulin regimens in relation to their eating and exercise patterns.

Treating dual defects in diabetes: insulin resistance and insulin secretion.

The therapeutic goals in patients with type 2 diabetes mellitus and the mechanisms of insulin resistance and secretion are discussed. Sulfonylureas improve glycemic control, restore the acute insulin response, and help improve beta-cell function in the short term. Meglitinides and phenylalanine derivatives and alpha-glucosidase inhibitors may be useful for elderly patients and others with normal fasting blood glucose levels and postprandial hyperglycemia, but they are less effective in achieving goal HbA1c levels in patients with marked fasting hyperglycemia.

Effective use of insulin.

Preview Day-to-day control of diabetes demands an ongoing balance of diet, exercise, and insulin dosage that can only be achieved with regular self blood glucose monitoring. Patients need to be familiar with factors that affect the action of insulin and to know that "less is sometimes more." In this article, Dr Bohannon explains the simple concepts that lead to the most effective use of insulin.