New SGLT-2 Inhibitor – Ertugliflozin

The Food and Drug Administration (FDA) has approved Ertugliflozin (Steglatro), a new SGLT-2 Inhibitor to treat adults with type 2 diabetes. Also approved are two new combination medications with ertugliflozin.  These include Segluromet (ertugliflozin plus metformin) and Steglujan (ertugliflozin plus sitagliptin). See box below for available combination doses (in mgs).

Dosing range: 5 -15 mg daily.  Monitor GFR before starting. Don’t start med if GFR is less than 60 and stop if GFR is less than 30.

Considerations: Ertugliflozin has the same warnings as other SGLT-2s: Watch for hypotension, UTI’s, increased urination, genital infections, ketoacidosis.

Benefits: no hypoglyecmia or weight gain.
Lowers A1c 1.0% – 2.0%. Lowers wt 1-3 lbs.

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

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)

World Diabetes Day Celebrates Dr. Banting and the Discovery of Insulin

During a hot summer in 1921, Dr.Banting secured space to test out his theory in the University of Toronto. Along with his colleague, Charles Best, and a bare bones lab, they conducted dozens of experiments on dogs, which ultimately led to the discovery of insulin. 

Dr. Banting and Charles Best began their experiments ligating the pancreases of dogs, thinking this would prevent destruction by the digestive pancreatic juices, and then isolating the extract from the islet cells. They then processed the extract from the islet cells and injected this extract they called “insulin” into diabetic dogs.  According to an audio Interview with Dr. Best, by July 1921, they had 75 positive examples of insulin lowering blood glucose levels in dogs. 

In February 1922, doctor Frederick Banting and biochemist John Macleod published their paper on the successful use of a alcohol based pancreatic extract for normalizing blood glucose levels in a human patient.

Here are some photos of the first insulin bottles produced by the University of Toronto and Eli Lilly.

Soon, word of their discovery got out and the race was on to produce enough insulin to treat the flood of type 1 patients arriving in Toronto to receive this miracle injection.

But, as with any amazing discovery, there is always more to the story. 

One of the biggest barriers to Banting was the simple fact that he was not involved in the field of diabetes research. The idea leading to the discovery of insulin came to him after preparing a lecture on the pancreas and diabetes, a subject he knew little about. He wasn’t a trained researcher and thus securing support for the project was initially difficult.

First Patients to Receive Insulin

The first patient to receive insulin was a ‘welfare’ case at Toronto General Hospital – no clinical trial structure to say the least. People from Canada/US flooded into Toronto to receive treatment. Banting struggled with the lack of accessibility of insulin – volume needed, issues of purification.

The earliest patients were “selected”, some youths from Canada/US, some soldiers with diabetes (probably because of Banting’s service in the First World War) and then later some select private patients. During this time they were working hard to increase the volume and continue to improve the purification process. Insulin was available for testing in US, namely through Dr. Elliot Joslin in the late summer 1922.

Takes a Team

While Best played a critical and important role, credit must also go to Professor Macleod, from the University of Toronto, who provided the lab space, showed Dr. Banting how to operate on dogs, provided his student Best and suggested they switch from a saline to alcohol to purify the ‘extract’.  Dr. Macleod also secured the support of JB Collip, the 4th man on the team and the fist person to purify insulin for human use. Best is also known for pushing Banting to return to the research during a particular dark period of failure.

Dr. Banting – Fun and Interesting Facts

• Sold insulin patent for $1
  
• Was wounded during the First World War and received the Military Cross
• Youngest Nobel Laureate in Medicine
• First Canadian on the cover of Time Magazine
• Among the last Canadians to receive a knighthood and have the title Sir Frederick Banting
• One of only two “non-Americans” to have a Second World War Liberty Ship named after him (USS Frederick Banting)
• Has as a crater on the Moon named after him (between Apollo 15 & 17 landing sites).

Want to Learn More About the Dr. Banting?

  Visit Banting House FaceBook Page

 

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Faster Aspart Insulin, Fiasp, Approved

A faster-acting injected mealtime insulin, Fiasp (“fast-acting insulin aspart”) is now FDA approved and expected to be available at the end of 2017 or early in 2018.

Fiasp is a new formulation of NovoLog, which includes the addition of niacinamide (vitamin B3) to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.

Fiasp is approved for adults with type 1 and type 2 diabetes and will launch at the same price as NovoLog. The newly-approved insulin has a faster onset and offset. On the front end, Fiasp starts working within minutes of injection and it can be taken as much as 20 minutes after starting a meal. While taking it at the beginning of the meal is strongly recommended, this dosing flexibility may be beneficial for some patients.

“The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management.” said Bruce Bode, MD FACE, President of Atlanta Diabetes Associates and Associate Professor at Emory University School of Medicine.

Fiasp will be packaged in Flex Touch Pens and 10mL vials.

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Novo Nordisk Press Release

Aspart (Fiasp) Package Insert

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Metformin Particularly Effective in Those With History of GDM – check out this article written in Medscape for more information. 

These latest findings come from the Diabetes Prevention Program (DPP) and its extension phase.

After 15 years from the start of DPP, women with a history of gestational diabetes taking metformin still had a 41% reduced risk of type 2 diabetes, compared with an 11% reduction in parous women with no history of gestational diabetes.

This contrasts with an overall effect of metformin in reducing the risk of type 2 diabetes by 18% in the study cohort as a whole.

“The overall results reinforce the long-lasting efficacy of metformin in reducing the development of diabetes and support its more widespread use as a prevention measure in those at high risk,” said David M Nathan, MD, director of the Diabetes Center at Massachusetts General Hospital, Boston, the study chair of DPP, who presented these latest results at the conference.

Asked for comment, Shubhada Jagasia, MD, professor of medicine and vice chair of clinical affairs in the department of medicine, Vanderbilt University Medical Center, Nashville, Tennessee, told Medscape Medical News that these new data should help doctors to target metformin treatment to those who will benefit most.

Women with a history of GDM who developed prediabetes that were started on Metformin decreased risk of developing type 2 diabetes by 41% at the 15 year mark. Wow.

 

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Interested in learning more about women and diabetes? Check out our Online University course:

Level 2 – Women and Diabetes 1.0 CEs – $19.00

Women with diabetes are confronted with a variety of issues that require special attention, education and understanding. This course reviews those special needs while focusing on Gestational Diabetes and Pre-Existing Diabetes.

 

There has been a lot of action at the FDA this year.  Several novel insulin combination medications were approved as well as the first “bio-similar” insulin, Basaglar.
We have kept our Diabetes Pocket Cards Up-to-Date on the CDCES Coach App and on our PocketCard Download Page.

New Insulin / GLP-1 Combo Pens

The FDA released the final dosing strategies and guidelines for IDegLira and iGlarLixi. These pen devices will be expensive for those without insurance coverage.

They offer users a unique opportunity to inject a once-a-day combination of basal insulin plus a GLP-1 Combination which has been show to effectively lower A1c in Type 2 Diabetes with less weight gain and hypoglycemia than with insulin alone.

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Insulin Updates

Basaglar has launched. This “copycat” basal insulin has the same amino acid sequence as Lantus. The list price, $316.85 for a pack of 5 pens is a 15% discount to Lantus and Toujeo, a 21% discount to Levemir, and a 28% discount to Tresiba.

Oral Medication Updates

Jardiance (empagliflozin) decreases CV Mortality by 38%. The (FDA) has approved empagliflozin (Jardiance),for the new indication of improving survival in adults with type 2 diabetes and cardiovascular disease (CVD). Important info to share!

Actos (pioglitazone) a new study seems to confirm that Actos may pose an increased risk for bladder cancer. A study published in BMJ earlier this year reported a 63% higher risk for bladder cancer with Actos.  Patients on Actos should report andy signs of bladder cancer (such as blood in the urine) and avoid if they have had a history of bladder cancer.

Synjardy XR – A new once-a-day combo medication was recently approved. Synjardy XR (empagliflozin and metformin XR). This medication reduces blood glucose and decreases risk of CV death without weight gain or hypoglycemia.

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