March 23, 2019 : Issue #982

• New Oral GLP-1 Application Submitted to FDA
• Using Glycemic Variability To Predict Major Cardiac Events In Patients with Type 2 Diabetes
• Does Intensive Blood Pressure Control Prevent Strokes?

This week we focus on cardiovascular health in two of our articles. Our two interns, Dahlia Elimairi and Ghazal Blair, wanted to focus on cardiovascular health because for so many of our patients this will be their most important focus to living a long life. We look at how large glucose swing can actually be used to predict cardiac events, and at how tight blood pressure control can decrease strokes with a low rate of side effects, and why more aggressive treatment is needed by most of our patients who have hypertension.

In addition, we have breaking news of the official submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oral tablet semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) analogue.

This week we are also introduced to a new FDA designation. Check out our new product of the week to find out what the new moniker Breakthrough Device Designation means.

*****************************

We can make a difference!

*****************************

Dave Joffe

Editor-in-chief

Novo Nordisk announced that it has submitted a new drug application (NDA) to the US FDA for oral semaglutide, the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in a pill. The company is seeking approval for oral semaglutide as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes. Novo Nordisk has submitted a priority review voucher to expedite the review time to six months.  The company also submitted a second NDA for oral semaglutide to obtain an indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and established cardiovascular disease (CVD). See article #1 for details.

The EOPancreas System is designed to provide closed-loop glucose control primarily for people with type 1 diabetes (T1D) and consists of a novel, integrated, wearable, disposable patch containing insulin delivery and continuous glucose monitoring (CGM) subsystems running a clinically validated closed-loop glucose control algorithm. The EOPancreas contains a unique, connected architecture, allowing the device to benefit from Artificial Intelligence (AI) algorithms running on a private, validated cloud — termed EOCloud — to allow customization of the closed-loop control for each patient. This new wearable pump weighs just 18gms, is tubeless and waterproof, has a bolus calculator, and will have a low glucose suspend along with CGM connectivity. Visit EOFlow.com.

Novo Nordisk requests approval for new type 2 treatment with heart benefits.

Too many highs and lows in glucose levels could be another reason that causes cardiovascular complications.

Maintaining a blood pressure below 130/80 mm Hg can eventually reduce the risk of having a repeat stroke, according to a recent study.

With all the new classes of drugs that have been approved over the last eight years, we are about to see one more new class of drugs. The new class is called dual GIP and GLP-1 receptor agonists, which have shown a greater weight loss result than the typical GLP-1 receptor agonists.

The first new drug in this new class is Tirzepatide, in development by Lilly (LY3298176). Tirzepaide has shown a weight loss result 4 times greater than Trulicity. The new phase 3 study, which is to show safety and efficacy data of Tirzepatide (LY3298176) to support FDA approval, is “Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4).” The study aims to enroll about 1,800 adults with type 2 diabetes at increased risk of heart disease. Participants will either receive Tirzepatide once a week or Lantus once a day. Phase 2 trial results, published in The Lancet, were recently presented at EASD 2018 showing that, compared to Trulicity (once-weekly injectable GLP-1 agonist), participants taking the highest dose of Tirzepatide had greater weight loss (25 lbs vs. 6 lbs) and greater A1C reduction (1.9% vs. 1.2%). Six-month data showed Hba1c reductions of up to 2.4% and an average weight reduction of up to 12.7%. An impressive 90% of Tirzepatide users had an A1C below 7% by the end of the trial. Side effects included nausea, diarrhea, and vomiting. The trial is enrolling across 168 locations, including several US states such as California, Florida, Massachusetts, and Texas. See a full list here. To get more information, contact Lilly at 1-877-285-4559 or clinicaltrials.gov@lilly.com.  Clinical Trials Identifier: NCT03730662.

Quote of the Week!

“Experience is simply the name we give our mistakes.”

…Oscar Wilde

Diabetes in Control gratefully acknowledges the assistance of the following pharmacy doctoral candidates in the preparation of this week’s newsletter:

Ghazal Blair, Pharm.D. Candidate 2019, LECOM School of Pharmacy

Dahlia Elimairi, Pharm D Student, UC Denver Skaggs School of Pharmacy

Your Friends in Diabetes Care
Steve, Dave, and Joy
Diabetes In Control
810 Bear Tavern Road Suite 102
Ewing, NJ, 08628
USA
www.diabetesincontrol.com