Oral GLP-1 RA lowers Weight and A1c
In a randomized phase 3a study published in Diabetes Care, those taking oral semaglutide monotherapy experienced superior and clinically significant improvements in A1c and weight loss compared to those taking a placebo.
Semaglutide (Ozempic) is currently only available as a once a week injectable, belonging to the GLP-1 Receptor Agonists classification. This class of medications is referred to as “Incretin Mimetics” since they imitate the action of gut hormones, causing satiation, post prandial glucose lowering and slowed gastric emptying. They have the added benefit of associated weight loss.
One drawback for people starting on semaglutide and all GLP-1 RAs, is that they currently can only be administered via injection.
Download FREE Diabetes Injectables PocketCard for more info on GLP-1 RAs.
The findings, based on the Peptide Innovation for Early Diabetes Treatment, or PIONEER, study, found that those who took either oral semaglutide 3 mg, 7 mg or 14 mg once a day for 26 weeks had significantly lower A1C and improved body weight, compared with those on placebo.
This phase 3a trial involving 703 people with type 2 diabetes provides hope that this medication class may be effective when administered orally.
The findings also showed that mild to moderate transient gastrointestinal incidents were the most common adverse events with the oral form of this GLP-1 receptor agonist.
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August Newsletter | Diabetes Medications Approved & Supplements Reviewed
August Newsletter Now Available!
In our August Newsletter, we highlight several exciting new releases! Nasal Glucagon has been approved, generic Dapagliflozin has been released, and Cleveland Clinic has synthesized a chart of supplements and their efficacy for people with diabetes!
Read this month’s newsletter before August 16 to see how you could get a $50 discount.
August Newsletter Topics Include:
- Nasal Glucagon Approved
- Nutritional Supplement Chart for People With Diabetes
- 5 Steps to Stop Sitting & Increase Longevity
- Diabetes Educator Conference “Making a Difference” Scholarship Awarded
- Generic SGLT-2 Inhibitor Approved
- New Technology Course & Networking Mixer at San Diego Live Seminar
- Women Leaders Conference Save the Date – December 6
- CDCES Coach App® Rated by DANA | $50 Discount for App Survey
Click here to read our newsletter
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Dapagliflozin biosimilar gets tentative FDA approval
The marketing application for a generic version of Farxiga, or dapagliflozin has received tentative approval from the US Food and Drug Administration (USFDA). Alembic Pharmaceuticals received a nod for its abbreviated new drug application for Dapagliflozin Tablets in 5 mg and 10 mg strength.
The approved product is therapeutically equivalent to the reference listed drug product Farxiga Tablets.
No information on pricing has been posted yet, but the hope is that as patents expire, more affordable generic diabetes medications will be made available.
Dapagliflozin belongs to the SGLT-2 Inhibitor class of diabetes medications. To read more, download our FREE Diabetes Medication Pocket Cards.
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Nasal Glucagon Approved – Time to Breathe a Sigh of Relief
The FDA just approved Baqsimi, a nasal glucagon powder to treat severe hypoglycemia in people with diabetes ages four and older. This first non-injectable form of glucagon should be available by the end of August. The U.S. list price for a Baqsimi one-pack is $280.80 and for a two-pack is $561.60.* This priceing is comparable to injected glucagon.
For people with diabetes and their loved ones, witnessing and treating severe hypoglycemia is scary. This new nasal treatment offers a fast and effective intervention for people at risk for severe hypoglycemia.
“This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”
said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The safety and efficacy of Baqsimi was evaluated in three studies; two with adults and one with pediatrics over the age of four with type 1 diabetes. The participant’s glucose levels increased sufficiently after the powdered glucagon was nasally administered.
Baqsimi comes in a single-use dispenser and does not need to be inhaled, which means it can be effectively administered to a person who is unconscious due to severe hypoglycemia.
Precautions
Baqsimi is not indicated in people with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas.
Baqsimi also carries a warning that it should be used with caution by those who have been fasting for long periods, have adrenal insufficiency or have chronic hypoglycemia because these conditions result in low levels of releasable glucose in the liver.
The most common adverse reactions associated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes and itchiness. Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and eye-related symptoms, such as watery eyes and nasal congestion, because of the way the drug is administered.
*Eligible commercially insured people with diabetes can pay $25 for up to two BAQSIMI devices (1 two-pack or 2 one-packs) with a savings card. This prescription is generally filled on an annual basis. Lilly may also be able to help people who don’t have commercial insurance coverage. Interested persons and healthcare professionals with questions about BAQSIMI can visit www.BAQSIMI.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
More info on Baqsimi approval at FDA Website – Click here
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Medical Myths – Top 10 List
Over 400 common medical practices were contradicted by rigorous research. For this blog, I highlight six widely held theories that are refuted by thousands of studies.
For all 10 myths below and more, we invite you to check out this scientific review led by Dr. Vinjay Prasad of Oregon Health and Science University who said, “Very smart and well-intentioned people came to practice these things for many, many years. But they were wrong.”
Myth – Fish oil reduces risk of heart disease
Truth – In a trial involving 12,500 people at risk for heart trouble, daily omega-3 supplements did not protect against heart disease.
Myth – Step counters and calorie trackers help people lose weight.
Truth – Based on a study of 470 “dieters” who were using digital assistance and tracked for two years, those who wore tracking devices actually lost less weight than those who followed standard advice.
Myth – A single dose of oral opioids to treat emergency room patients works better than medications like aspirin and ibuprofen.
Truth – Clinical trial showed that medications like aspirin and ibuprofen are much safer alternatives which relieve pain just as well among emergency room patients.
Myth – Ginkgo biloba protects against memory loss and dementia
Truth – Made from the leaves of ginkgo trees, this supplement was widely used is promoted as a way to preserve memory. A large federal study, published in 2008, definitively showed the supplement is useless for this purpose.
Myth- Peanut allergy risk is higher if a child is exposed to peanuts before age three.
Truth – Children exposed to peanuts before age 1 have no greater risk of peanut allergies.
Myth – Lifelike doll carried around by teenager will prevent unplanned pregnancy
Truth – It turns out that these “infant simulators” were actually associated with a slightly increased risk of pregnancy.
For a complete list as published in the New York Times article, 10 Medical Myths We Should Stop Believing. Doctors, Too.
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Victoza, now approved for children with Type 2
Novo Nordisk announced, liraglutide (Victoza) has been approved for young people with Type 2 diabetes between the ages of 10-17 years old.
The U.S. Food and Drug Administration has approved the medication for children that was previously only approved for adults.
“As the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, liraglutide (Victoza) provides this population with a new treatment option beyond metformin and insulin for the first time in 19 years.”
With the increasing rates of Type 2 diabetes in children, this offers clinicians a new treatment option outside of metformin and insulin.
“Type 2 diabetes is the most common form of diabetes, normally occurring in people 45 years or older, but its prevalence among the younger population has climbed dramatically over the past 20 years.”
Type 2 diabetes, which was once considered a rare condition in the pediatric population, now accounts for about 15% to 45% of all newly diagnosed cases of diabetes in children and teenagers.
The approval of liraglutide (Victoza) could help considerably with the treatment of Type 2 in children.
Original Article: FDA approves Victoza® for the treatment of type 2 diabetes in children and adolescents aged 10-17 years – Novo Nordisk
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Express Scripts to Charge max of $25 a month for insulin
More than 30 million Americans have diabetes and approximately 7.4 million require insulin. Between 2002-2013, the average price of insulin nearly tripled, creating financial hardships for people who rely on it to survive.
One company, Cigna’s Express Scripts, is working to lower the price for consumers by the end of the year. “Express Scripts, which manages prescription drug insurance for more than 80 million people, is launching a “patient assurance program” that Steve Miller, Cigna’s chief clinical officer, says “caps the copay for a patient at $25 a month for their insulin — no matter what.”
As the voices of people who rely on insulin are beginning to be heard, lawmakers are starting to take notice. The increase in prices has been deadly for some.
The full retail price of some insulins can cost up to $1,400 per month. Under Scripts new program, people who normally would have to meet their deductible will stay pay only $25 per month for their insulin.
A recent study conducted at Yale found that 25% of people utilizing insulin will dilute or skip doses altogether in order to save money. This can a
“The bottom line is that drug prices are set by drug makers,” he told lawmakers. “The list price for insulin has gone up dramatically — and that’s the price that many patients pay. This is what needs to come down. It’s as simple as that.”
Express Scripts will begin to offer the $25 co-pay deal close to the end of the year to those not covered by a government insurance program.
Insulin should be affordable for all. Click here for additional resources on how you can make a difference.
To learn more: “Express Scripts Takes Steps to Cut Insulin’s Price to Patients” – NPR
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Type 2 diabetes: Gut bacteria may influence drug effectiveness
415 million people across the globe have Type 2 Diabetes and it is now considered a “global epidemic.”
Diabetes drugs have varying success from person to person. New research conducted by Hariom Yadav, Ph.D., an assistant professor of molecular medicine at the Wake Forest Baptist Medical Center, studies have suggested that gut bacteria is a key indicator to a drug’s success. This research suggests a correlation between medication effectiveness and the gut bacteria of a person with Type 2 Diabetes.
“For example,” explains the lead researcher, “certain drugs work fine when given intravenously and go directly to the circulation, but when they are taken orally and pass through the gut, they don’t work.”
Metformin on the other hand works best when given orally. Based on the study, researchers believe that the individuals’ gut bacteria are affecting how well a person metabolizes the medication.
The study focused on whether or not the microbiome “boosted or inhibited” the effectiveness of the medication. “Our review showed that the metabolic capacity of a patient’s microbiome could influence the absorption and function of these drugs by making them pharmacologically active, inactive, or even toxic,” said Yadav.
Although this field of research is only about 10 years old, there are strong signs that our gut microbiome play a key role in our overall health this may include how we interact with medication. Yardav plans to continue to study the gut bacteria as it relates to the treatment of disease.
To learn more: “Type 2 diabetes: Gut bacteria may influence drug effectiveness” by Medical News Today
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