New Copycat Bolus Insulin

The Food and Drug Administration (FDA) has approved Admelog (Sanofi-Adventis US), the first copycat version of short-acting insulin lispro (Humalog, Eli Lilly)  to treat individuals aged 3 years and older with type 1 diabetes and adults with type 2 diabetes.

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Features:

Approved for use as an injection, via pump, or intravenously.

It will be available both in vials and as a prefilled pen (Admelog SoloStar).

The FDA approved Admelog through an abbreviated approval pathway under which companies can rely on the FDA’s previous approval of a drug as safe and effective or on previously published literature supporting safety and/or effectiveness. This process is meant to reduce drug development costs in order to reduce the drug’s price on the market.

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Medication Update Webinar – Feb 19, 2018 11:30 to 1pm (PST)

New GLP-1; Semaglutide (Ozempic)

The US Food and Drug Administration (FDA) has approved semaglutide (Ozempic, Novo Nordisk) as an adjunct to diet and exercise for the treatment of type 2 diabetes in adults.

This once weekly injection of (GLP-1) receptor agonist will be available in 0.5-mg and 1.0-mg doses, via a dedicated prefilled pen device.

Semaglutide is the seventh GLP-1 receptor agonist on the US market and the third dosed once weekly.
And the data suggests it might be more effective than some of its competitors.

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Features:

The company’s eight phase 3a trials involved over 8000 adults with type 2 diabetes, including individuals at high cardiovascular risk and those with renal disease. One of the studies, SUSTAIN-6, was a 2-year FDA-mandated cardiovascular-outcomes trial involving 3297 patients.

• In the five SUSTAIN efficacy trials, semaglutide reduced hemoglobin A1c by 1.5 to 1.8 percentage points.
• Semaglutide was also associated with a 4.5- to 6.4-kg weight loss. The most common side effect was mild to moderate nausea, which diminished over time.

After approval, Novo Nordisk is required to conduct a pediatric trial in adolescents younger than 18 years of age and to add semaglutide to a 15-year medullary thyroid carcinoma registry that includes all of the long-acting GLP-1 products.

Semaglutide will be priced similarly to current weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce copays for eligible commercially insured patients.

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Medication Update Webinar – Feb 19, 2018 11:30 to 1pm (PST)

Bydureon BCise Injector

The once weekly GLP-1 Receptor Agonist, Bydureon, is a dual chambered pen that requires mixing and assembly that was challenging for some patients.

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To improve the patient experience, a new extended release pre-filled delivery device, Bydureon BCise – has been approved by the FDA. for adults with type 2 diabetes. The new autoinjector features a simpler mixing process, a hidden needle, and a viewing window for users to confirm that they’ve received the medication.

Features of Bydureon BCise (rhymes with “precise”) is expected to launch in early 2018.

• Easier mixing: To prep the BCise pen for injection, the user simply has to shake it for 15 seconds. By comparison, the older dual-chambered pen instructed users to tap it “80 times or more.”

• Pre-attached needle: With the dual-chambered pen, users had to screw on the needle cap. Bydureon BCise comes with a hidden needle.

• Easier injection: To administer Bydureon BCise, users are directed to push the pen against the skin and hold for 15 seconds, removing the hassle of needle insertion and holding down the plunger.

To get the new autoinjector, healthcare professionals must write a prescription specifically for Bydureon BCise. AstraZeneca has not specified what the price of Bydureon BCise beyond suggesting that it will be comparable to the dual-chambered pen pricing.

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Medication Update Webinar – Feb 19, 2018 11:30 to 1pm (PST)

Question of the Week & Rationale 

Our “Question of the Week” is created weekly by Coach Beverly to cover a variety of Diabetes related topics. The questions are designed to keep you current and prepare you for the CDCES® Exam.

To sign up to receive the question of the week, download our free CDCES Coach App or join our Facebook Page. 

This week’s Rationale: Question of the Week – December 12th – test your knowledge before seeing answer below! 

What a perfect way to information share and bring new concepts to light. We appreciate our community of diabetes educators and the opportunity to keep learning together! 

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Question:

A patient has prediabetes and asks you if he can prevent getting diabetes if he loses weight and gets active. What is the most accurate response?

a. By losing visceral fat and walking, you can prevent diabetes.

b. By taking care of your health today, you won’t get diabetes tomorrow.

c. People who get 30 mins of exercise a day and lose 7% of weight, have a decreased risk of getting diabetes.

d. People who get 30 mins of exercise a day and lose 7% of weight eliminate risk of getting diabetes

Correct Answer:  People who get 30 mins of exercise a day and lose 7% of weight, have a decreased risk of getting diabetes.

Rationale: Wow, 92% of you got this one right. Great job!

The Diabetes Prevention Program demonstrated that people with prediabetes who got active and lost 7% of their body weight, decrease risk of getting diabetes over 3 years, by 58%.  And if they were 60 and older, they decreased risk by 70%.

 For more information on starting  a Diabetes Prevention Program in your community, please visit our Prevention Resource Page.