New Diabetes Treatments and Clinical Practice Aids

EndocrineWeb features highlights of recent government activities, new product announcements, and brief study findings to keep you informed of advances in diabetes care management.

New Oral Medications Approved for Type 2 Diabetes

As type 2 diabetes progresses, patients may require additional medications, or a variation from initial therapy, to help them better manage their blood glucose levels.

Coming Soon—The Food and Drug Administration granted Merck/Pfizer approval to introduce ertugliflozin, expanding the options for oral sodium-glucose cotransporter 2 (SGLT2) inhibitors for the management of type 2 diabetes.1

To be sold under the brand name Steglatro, joins an expanding array of SGLT2 inhibitors, including AstraZeneca’s Farxiga, Johnson & Johnson’s Invokana, and Jaridance from Eli Lilly and Boehringer Ingelheim.

 

EW brings endocrinologists the latest in diabetes medications, glucose products, and clinical guideline

This approval permits Merck and Pfizer to market Steglatro as single therapy as well as Steglujan, a fixed dose combination with sitagliptin (Januvia), a DDP-4 inhibitor, or as Segluromet in combination with metformin.

These new medications will be available in early 2018, according to the companies, and marketed by Merck.

Januvia, a DPP-4 inhibitor, gained considerable attention this past year for its clinical efficacy in reducing cardiovascular risks,2 in combination with ertugliflozin, which will compete with Eli Lilly (Glyxambi, Januvia, and Tradjenta).  Similar efficacy for cardiovascular risk reduction was shown with Invokana.3

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Injectable Insulin Options Expand

Approved in 2017,4 Novo Nordisk announced the availability of two new diabetes medications, Ozempic (semaglutide), and Fiasp, an insulin aspart injection (100 Units/mL) at pharmacies across the United States.

Ozempic, a once-weekly glucagon-like peptide (GLP-1) receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The once-weekly semaglutide is approved for use in two therapeutic dosages: 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen. It’s intended administered is once weekly (preferably on the same day each week), at any time of day with or without meals.

In clinical trials,5,6 Ozempic demonstrated statistically significant hemoglobin A1C reductions. Andrew J. Ahmann, MD, professor of medicine and Harold Schnitzer Director of the Harold Schnitzer Diabetes Health Center at Oregon Health & Science University in Portland, Oregon, lead an open-label study of patients whose ages, body weight (body mass index), duration of diabetes, and hemoglobin A1c levels varied. The study was supported by funds from NovoNordicks who also provided funding to Dr. Ahmann.

This once-weekly [antidiabetic therapy] administered through small gauge needles seem to provide a desirable option when treating patients with type 2 diabetes who have failed oral agents,5 Dr. Ahmann said.

According to the company,4 Ozempic would be priced at parity to current market-leading weekly GLP-1 receptor agonists, although eligible patients with commercial insurance would be able to apply for an “instant savings card” to reduce co-pays to as low as $25 per prescription for up to two years. www.OzempicSavings.com 

Fiasp is the first fast-acting mealtime insulin injection that does not carry a pre-meal dosing requirement and is indicated to improve glycemic control in adults with either type 1 and type 2 diabetes.

Fiasp should be administered at the beginning of a meal or within 20 minutes after starting a meal since its absorption into the blood in immediate (~ 2.5 minutes). Similarly, the price for Fiasp will be comparable to mealtime insulin NovoLog® and also eligible for a Novo Nordisk Instant Savings Card to reduce co-pays to as low as $25 for a 30-day supply for up to two years.

Fiasp® should be administered at the beginning of a meal or within 20 minutes after starting a meal since its absorption into the blood in immediate (~ 2.5 minutes). Similarly, the price for Fiasp will be comparable to mealtime insulin NovoLog® and also eligible for a Novo Nordisk Instant Savings Card to reduce co-pays to as low as $25 for a 30-day supply for up to two years. www.MyFiaspSavings.com.

"With 1.5 million new patients diagnosed with diabetes each year,7 we must continue to innovate and bring to market new options to meet the diverse needs of patients," said David Moore, senior vice president, at Novo Nordisk, in a corporate press release. The company stressed that since there is no one-size-fits-all approach to effectively manage people with diabetes, adding these two new formulations expands the options available to patients, particularly around dosing and administration.4
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AACE/ACE 2018 Comprehensive Type 2 Diabetes Management Algorithm 

The eagerly anticipated Comprehensive Type 2 Diabetes Management Algorithm has been released by the American Academy of Clinical Endocrinologists.8  These latest evidence-based recommendations for the treatment of T2D is now accessible online.

The 2018 edition includes an updated section on lifestyle therapy, as well as a discussion on all classes of obesity, antihyperglycemic, lipid-lowering and antihypertensive medications approved by the FDA. The AACE/ACE T2D Management Algorithm and executive summary were published in Endocrine Practice. 8

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Resistance to Acetaminophen Interference Found in Novel CGM System

In exploring advantages of the Dexcom G6, a novel investigational real-time continuous glucose monitoring (rtCGM) system, industry-sponsored research by Calhoun et al9 explored the potential to filter out acetaminophen. To assess this, the research team compared the differences in glucose levels with the G6 rtCGM, using a standardized measure (YSI) from one hour before to six hours. The dose of acetaminophen was monitored in 66 individuals with diabetes (either type 1 or type 2). The interference effect was defined as the average post-dose (30-90 minutes) bias minus the average baseline bias for each person.

With a clinically meaningful interference effect defined as 10 mg/dL, the G6 system achieved a significantly lower mean interference effect (3.1 ± 4.8 mg/dL; one-sided upper 95% CI = 4.1 mg/dL).9 The resistance to acetaminophen interference system achieved by G6 offers clinical reassurance for patients with diabetes who are in need of this medication while relying on rtCGM to manage their glucose levels.

Continue Reading:
Cardiovascular Disease Risk and Mortality in Adults with Type 1 Diabetes
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