Top 5 Diabetes Stories for the Year

Diabetes is a growing epidemic that is quickly spiraling out of control in the United States. New research has indicated that half of healthy 45-year-olds will develop pre-diabetes and one-third will develop diabetes at some point.

The disease affects approximately 30 million Americans and is the seventh leading cause of death in the United States, according to data from the National Diabetes Statistics Report, 2014.

Here are the top 5 articles from the last year on diabetes.

Toujeo and Afrezza: New and Improved Insulins, Limited by FDA Labeling Constraints

Two new insulins marketed by Sanofi offer improved options for patients: Toujeo is longer acting than its predecessor, Lantus. Afrezza, an inhaled insulin, is gaining praise from patients, if not from Wall Street.

Trial data indicate that Toujeo controls glycated hemoglobin (A1C) levels about as well as Lantus, an insulin glargine formulation approved in the year 2000 that has just lost patent protection after years of blockbuster sales. Toujeo lasts longer than Lantus, however.1 It also provides the body a steadier stream of insulin1 and is associated with a significantly lower risk of nocturnal hypoglycemia.

Afrezza performed similarly in a phase 3 trial. It roughly matched an existing competitor, insulin aspart (Novolog), in A1C reduction, and slightly outperformed it in several secondary ways. Afrezza use was associated with less hypoglycemia, lower fasting blood glucose, and slight weight loss rather than slight weight gain. It also reached peak levels very quickly, in just 12 to 14 minutes on average.

Read the article.

Sanofi Addresses Need for Spirometry Before Physicians Can Prescribe Afrezza

Rarely does a new therapy generate as much divided opinion and passion as Afrezza, the inhaled insulin developed by MannKind Corporation and now marketed by Sanofi.

The fast-acting human insulin, administered through an inhaler that fits in a palm, has won loyal fans among users with type 1 diabetes mellitus (T1DM). Those who praise the product cite its ability to provide better glycemic control as well as a winning design, which offers convenience that those with T1DM have long sought.

And then, there are the skeptics: throughout the spring, analysts who follow MannKind reported slower than expected sales and reluctance from some physicians to prescribe the product, often because of a requirement imposed by the FDA at approval: Because the insulin powder is inhaled, underlying lung problems must be ruled out before a patient can gain access to the therapy. (Afrezza is not indicated for patients with chronic obstructive pulmonary disorder or other chronic lung diseases, such as asthma. Safety and efficacy in patients who smoke have not been established.)

Ruling out lung problems requires spirometry, a test that until now may have been uncommon among endocrinologists, although it better known among primary care physicians.

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Changing Trends in Type 2 Diabetes Mellitus Treatment Intensification, 2002-2010

Glycemic control can lower the risk of diabetes-related complications, and delayed treatment intensification can impede optimal diabetes care. This study examines trends in hyperglycemia treatment intensification between 2002 and 2010.

Take-Away Points

This study examines trends in treatment intensification among privately insured adults of all ages in the era of greater focus on quality improvement and performance measurement for diabetes.

• In a geographically and demographically diverse population, time to treatment intensification decreased consistently between 2002 and 2010.
• This study specifically addresses the selection of second-line agents as add-on therapy to metformin in routine clinical practice. The use of incretin agents and insulin increased significantly over the past decade, while the use of thiazolidinediones has decreased.
• Sulfonylureas remained the most commonly prescribed class of second-line agents used to treat type 2 diabetes mellitus.

Read the paper.

Cost Efficiency of Canagliflozin Versus Sitagliptin for Type 2 Diabetes Mellitus

Objectives: To compare 1-year clinical outcomes and cost efficiency of treating adults with type 2 diabetes mellitus (T2DM) with canagliflozin (300 mg/day) or sitagliptin (100 mg/day), both added on a background of metformin and sulfonylurea.

Study design: An economic model integrated data from an active-controlled, randomized trial, claims database analyses, and published literature.

Methods: The model adopted a US managed care payer perspective and included the clinical and economic impact of achieving specific clinical quality goals. The model was run separately for 2 single clinical quality metrics, glycated hemoglobin (A1C) <7% (used as base case) or <8%, and 4 composite metrics (A1C <7% or <8% combined with body mass index <30 kg/m2 and blood pressure <140/90 mm Hg or low-density lipoprotein cholesterol <100 mg/dL). Cost savings of achieving versus not achieving metrics were derived from a claims database analysis. Drug and adverse event costs were included.

Results: In the base case, compared with sitagliptin 100 mg, treatment with canagliflozin 300 mg resulted in $215 in annual cost savings and 12.3 absolute percentage points more patients achieving goal. Similar findings were found across all other quality metrics (difference in proportion achieving goal ranging from 6.7% to 19.0% and annual savings ranging from $1 to $669). Canagliflozin remained cost saving versus sitagliptin in sensitivity analyses.

Conclusions: Canagliflozin 300 mg may represent a cost-efficient T2DM treatment option versus sitagliptin 100 mg for patients on metformin plus sulfonylurea due to lower overall costs and better achievement of A1C and quality composite goals.

Read the paper.

Medicare’s Failure to Cover CGM at Odds With Other Health, Research Agencies

“The lives of people living with, and at risk for, diabetes are better because of National Institutes of Health (NIH) research and CDC prevention activities. Due to the Special Diabetes Program, which was renewed as part of the Medicare Access and CHIP Reauthorization Act of 2015, and increased investments in diabetes research, we have seen some encouraging breakthroughs and are on the threshold of a number of important new discoveries. We’ve made progress, but much more must be done.

This is particularly true for the estimated 1.2 million Americans living with type 1 diabetes (T1D). Advances in technology, such as continuous glucose monitors (CGMs), are helping patients control their blood glucose levels, which is key to preventing costly and sometimes deadly diabetes complications. We are also moving closer and closer to our goal of an artificial pancreas, which would control blood glucose levels automatically and revolutionize diabetes care.

The NIH and the FDA have been extremely supportive of these innovations in diabetes care. As chairman of the Senate Aging Committee, I was surprised and troubled to learn that insulin dependent Medicare beneficiaries with T1D are being denied coverage for CGM technology because CMS has determined that they do not meet the Medicare definition of durable medical equipment and do not fall under any other Medicare category.”

A leading voice on diabetes care asks why Medicare still will not cover CGM technology.Read the article.