Reece's Piece's In a Diabetes World

Hypoglycemia is serious business. Timely treatment is essential. We now have an additional option for treatment of hypoglycemia. Dasiglucagon (brand name Zegalogue) is a human glucagon analogue that is approved for treatment of severe hypoglycemia in persons with diabetes 6 years of age and older. The three studies assessing efficacy of dasiglucagon included children 6 – 17 years old and adults with type 1 diabetes. On average, the median time to glucose recovery was 10 minutes across the three studies. To learn more about this new option for treatment of hypoglycemia, please click below.

https://www.healio.com/news/endocrinology/20210323/fda-approves-rescue-pen-for-treating-severe-hypoglycemia?utm_source=selligent&utm_medium=email&utm_campaign=topicalert&M_BT=4557970002905

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#dasiglucagon #hypoglycemia #treatment

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Contributor: Quynh Nguyen, PCOM Georgia PharmD Candidate Class of 2022

CB, 50 year old female with 10 year history of type 2 diabetes, recently shared her frustration of struggling to lose weight. While her A1c is below 7%, the scale will not budge. She feels like her diabetes medications are working great in lowering her blood glucose but not so positive impact on her weight. CB is not alone in her frustration as one of the frustrations that I most commonly hear from persons taking insulin is the weight gain.  Often, glucagon like peptide 1 (GLP-1) agonists can be an alternative to insulin as this class of drugs effectively lowers glucose and body weight as well as protects the heart.  Within the GLP-1 agonist class, semaglutide has been shown in clinical trials to have the greatest body weight reduction.  Recently, results from two clinical trials, STEP 1 and 2, have shed additional light on the weight loss benefits of semaglutide.  In both trials, life management (dietary and physical activity), a vital foundation, was combined with semaglutide.  

STEP 1 study used  a combination approach of lifestyle management along with once-weekly 2.4mg of semaglutide for weight loss in obese patients. In this study, a total of 1,961 adults who had a body mass index (BMI) of 30 or higher, or those with a BMI of 27 or greater with at least one weight-related disease (hypertension, liver disease, various cancers) were enrolled in this trial.  Semaglutide was initiated at 0.25mg once weekly for the first four weeks, and then the dose increased every four weeks until the target dose of 2.4mg was reached. All adults in the study received lifestyle counseling (dietary and physical activity management). Data indicates within the first four weeks of initial treatment, those receiving semaglutide had more than a 2% reduction in their body weight, and continued losing weight the remainder of the 68 week trial. Furthermore, about 70% of those receiving semaglutide and lifestyle management were able to lose 10% of their weight, and about 50% were able to lose 15% of their body weight. STEP 1 study showed that in total, the adults on semaglutide treatment lost an average of 33.7 lb  by the end of 68 weeks. Overall, the study provided promising results for those who want to lose weight. An average weight loss of 14.9% was achieved for those receiving semaglutide 2.4 mg and lifestyle management, versus the 2.4%  of those on lifestyle management only. These promising results must be balanced with mild to moderate side effects of nausea, diarrhea, vomiting, and constipation. 

STEP 2  study was similar to STEP 1 in using a combination approach of lifestyle management and semaglutide 2.4 mg once weekly except in persons with type 2 diabetes and BMI of at least 27.  This STEP 2 trial included 1,210 patients with diabetes who had a BMI of at least 27, from all across the globe ranging from North and South Americas, Europe, Middle East, South Africa, and Asia. There were three different groups for this trial: one group receiving the higher dose of semaglutide which was 2.4mg, a second group receiving 1.0mg of semaglutide, and the last group, not receiving any dose of semaglutide.  All three groups received lifestyle modification counseling. The two groups receiving the semaglutide began with 0.25mg weekly dose, and then the dose was increased until the target dose of 2.4 mg was reached.  The semaglutide groups lost an average of 9.6% of their initial starting body weight compared to the 3.4% for those not receiving semaglutide. After 68 weeks, those receiving semaglutide 2.4 mg once weekly had a five-fold higher chance of achieving at least 5% body weight reduction versus those who did not receive semaglutide. Furthermore, about 69% of those on the higher dose (2.4mg) had improvements in their overall health including waist circumference, blood pressure, blood glucose, and physical functioning. Side effects of semaglutide were similar in STEP 1 and 2. Higher dose (2.4 mg) semaglutide provided great weight loss results for those with diabetes and BMI at 27 or higher. 

The results of these trials revealed the effectiveness of using semaglutide 2.4mg weekly for weight loss, in those with and without diabetes who have a BMI at 27 or higher.  As a result of these trials, NovoNordisk has submitted an application to the FDA for weight reduction indication in those with and without diabetes for the 2.4 mg dosage of semaglutide.  So be on the lookout for this as a future option for weight loss for those with or without diabetes.  

Back to CB, she and I discussed her trying semaglutide once weekly in place of her daily sitagliptin.  When she followed up, she was pleasantly surprised to see the scale finally moved in the right direction. 

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#semaglutide #weight loss #diabetes

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We currently have glucagon like peptide 1 agonists (i.e. Ozempic, Trulicity, Victoza) available for treatment of type 2 diabetes. Tirzepatide, a once weekly glucose-dependent insulinotropic polypeptide and glucagon like peptide 1 agonist, is currently in phase III clinical trials (name of trials are SURPASS-3 and SURPASS-5). The results of A1c reduction by 2.37 percent and body weight by 12.9 kg (28.4 lbs) are very promising. Both studies were well designed with SURPASS- 3 comparing tirzepatide (5 mg, 10 mg, 15 mg) with insulin degludec in adults with type 2 diabetes not at glycemic goals on metformin +/- SGLT-2 inhibitor over 52 weeks. SURPASS-5 compared safety and efficacy of tizepatide (5 mg, 10 mg, 15 mg) with placebo with both as an add on to insulin glargine +/- metformin in adults with type 2 diabetes. In both SURPASS-3 and SURPASS-5, the primary and secondary endpoints were met. It is worth noting that the most common adverse effects of tirzepatide were GI related not surprising considering its mechanism of action. Please click below for more details regarding SURPASS-3 and SURPASS-5.

https://investor.lilly.com/news-releases/news-release-details/tirzepatide-significantly-reduced-a1c-and-body-weight-people

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#tirzepatide #novel #A1c #weight #diabetes

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Contributor: Ja’Davia Schafer, M.S., PCOM Georgia D.O. Candidate Class of 2023

RM with type 2 diabetes, arthritis and heart condition recently inquired about whether a fish oil supplement would be beneficial for her. She is currently taking insulin degludec, empagliflozin and semaglutide for her diabetes as well as rosuvastatin for her cholesterol.  Would a fish oil supplement or prescription product be appropriate for RM?

According to the 2010 Dietary Guidelines reported by the National Center for Complementary and Integrative Health (NCCIH),  it was recommended that individuals consume a variety of 8 ounces of fish or more per week due to the variety of nutrients provided (1). Many individuals supplement this with a dosage of 250–500 mg over-the-counter fish oil pills per day (2). This is the recommended dosage for the average healthy adult in the United States, however, they should not serve as a full replacement of whole foods. 

These translucent yellow supplements contain Polyunsaturated fatty acids (PUFA). One key subgroup of PUFA is omega-3 fats including, Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is found primarily in fish and fish oils (3). Extensive research studies have shown that diets high in EPA and DHA have significantly lowered the risk of heart  and other inflammatory diseases (4). Diets high in PUFA and monounsaturated, such as the Mediterranian diet, have shown to reduce the instances of coronary artery disease, ischemic strokes, and lowering cholesterol (5, 6). Individuals with pre-existing heart conditions also benefit from taking OTC fish oil supplements, however, these patients have better outcomes from taking prescription medications such as statins (HMG CoA reductase inhibitor that reduces the production of cholesterol) or prescription omega-3 PUFA formalations (7). (an FDA approved ethyl esters of omega-3 fatty acids that contain a higher amount of DHA and EPA). The FDA approved prescription omega-3 PUFA formulations are indicated for treatment of triglyceride levels of 500 mg/dL or greater. 

•      LovazaⓇ (omega-3 acid ethyl ester of EPA/DHA)
•      EpanovaⓇ (omega-3 carboxylic acid of EPA/DHA)
•      VascepaⓇ (ethyl ester of EPA only)

The amount of EPA/DHA per capsule is 1 gram in the prescription omega-3 PUFA formulations and less than 300 mg per capsule OTC fish oil supplements (8).  For prescription formulations,  the total daily dose is 2 – 4 grams. Typically an OTC fish oil supplement can be purchased for less than $10 (Look for the buy one get one FREE deals.) while the prescription fish oil products will be at least $40 without insurance coverage.  In terms of side effects, some people may notice a “fishy” taste, dyspepsia (with LovazaⓇ) or increased risk of bleeding event (VascepaⓇ) (so be cautious if you have a history of bleeding event). 

Questions you should ask during your provider visit regarding fish oil:

1. Can I take a fish oil supplement or prescription product  considering all of my current health conditions? 
2. Can I take a fish oil supplement or prescription product with my other medication? 
3. Do I need to separate when I take fish oil from my other medications?
4. Would a fish oil supplement or prescription product be better for me?
5. Can I take these supplements while pregnant? 
6. What are some signs that I may be deficient in omega 3 fatty acids? 

Back to RM, after collaborating in the decision making process, a prescription fish oil product was selected.  RM followed up in a week sharing that she has tolerated it without any side effects. 

References:
1. 7 Things to Know About Omega-3 Fatty Acids. National Center for Integrative Health.  

https://www.nccih.nih.gov/health/tips/things-to-know-about-omega-fatty-acids#pdf. Accessed on February 20, 2021. 

2. Interim Summary of Conclusions and Dietary Recommendations on Total Fat & Fatty Acids. The Joint FAO/WHO Expert Consultation on Fats and Fatty Acids in Human Nutrition. Nov 2008. https://www.who.int/nutrition/topics/FFA_summary_rec_conclusion.pdf?ua=1. Accessed on February 20, 2021. 

3. PM Kris-Etherton, Denise Shaffer Taylor, Shaomei Yu-Poth, Peter Huth, Kristin Moriarty, Valerie Fishell, Rebecca L Hargrove, Guixiang Zhao, Terry D Etherton. Polyunsaturated fatty acids in the food chain in the United States. The American Journal of Clinical Nutrition, Volume 71, Issue 1, January 2000, Pages 179S–188S, https://doi.org/10.1093/ajcn/71.1.179S

4. H Gerster. Can adults adequately convert alpha-linolenic acid (18:3n-3) to eicosapentaenoic acid (20:5n-3) and docosahexaenoic acid (22:6n-3). Int J Vitam Nutr Res. 1998;68(3):159-73.

5. Why the Mediterranean Diet is Good for your Heart. Harvard Women’s Health Watch. https://www.health.harvard.edu/heart-health/why-the-mediterranean-diet-is-so-good-for-your-heart. Accessed on February 20, 2021. 

6. Miguel A. Martínez-González, Alfredo Gea, Miguel Ruiz-Canela. The Mediterranean Diet and Cardiovascular Health. Circulation Research. 2019;124:779–798. https://doi.org/10.1161/CIRCRESAHA.118.313348

7.L DeDea. When to take statins; Lovaza versus OTC Fish Oil Supplements. Journal of the American Academy of PAs. 2001;24(5):23. 

8.  MS Kelly, C Beavers, JD Bucheit, et al. Pharmacologic approaches for the management of patients with moderately elevated triglycerides (150 – 499 mg/dL). J Clin Lipidol, 2017;11:872-879.

Sotagliflozin, a drug that works in the kidneys to increase amount of glucose released into urine for elimination, is currently pending FDA approval for treatment of type 2 diabetes. Data from clinical trial for sotagliflozin revealed possible reduction in hospitalization or urgent visits for heart failure and cardiovascular (heart) related death in persons with diabetes and chronic kidney disease. The concern with this study is lack of power so further studies are needed. To learn more, please click below.

Bhatt DL, Szarek M, Pitt B, et al; SCORED Investigators. Sotagliflozin in patients with diabetes and chronic kidney disease. N Engl J Med. 2021;384:129-139. doi:10.1056/NEJMoa203018

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#sotagliflozin #heart #benefit

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I am super excited about this study of once weekly semaglutide (you may recognize the injectable brand of Ozempic) plus lifestyle interventions (changes to eating habits and moving more) in persons without diabetes and with body mass index of 30 or greater for weight loss. Semaglutide works in the satiety center (which controls hunger) in the brain to decrease hunger which works great in combination with changing eating habits and moving more. The results of the study are promising. I hope that semaglutide will be approved for weight loss in persons without diabetes, and this study is a step towards making this approval happen in the future.

https://www.nejm.org/doi/full/10.1056/NEJMoa2032183

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#semaglutide #weight #loss #medicine

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We have been taught to store insulin in refrigerator (35.6 – 46.4 degrees Fahrenheit) at least until first use of the vial or pen then at at 77 degrees for up to two – four weeks (varies depending on product). A study by researchers from Doctors Without Borders and the University of Geneva has shown that refrigeration might not be necessary. In this study, they test insulin in more real world conditions with temps ranging from 77 to 98.6 degrees Fahrenheit for four weeks. Interestingly in the study the insulin only lost no more than 1% potency (current regulations allow for up to 5% potency). These findings particularly helpful for places of fewer resources where access to refrigeration is limited.

https://consumer.healthday.com/b-2-4-insulin-may-not-need-refrigeration-freeing-up-its-use-in-poorer-nations-2650234326.html

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#insulin #storage #diabetes

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Novo Nordisk has submitted to the FDA for approval of higher dose (2 mg) Ozempic which is currently available in 0.5 mg and 1 mg once weekly injectable doses. The potential for additional lowering of hemoglobin A1c and weight loss with higher dose. Recently, Trulicity (also an injectable once weekly GLP-1 agonist) was FDA approved for higher dosing (3 mg and 4.5 mg). I look forward to the FDA approving the 2 mg dose of Ozempic as this provides more options for persons with type 2 diabetes to have greater decrease in glucose and weight loss.

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#FDA #diabetes #medication

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WE are in a new year! Thank goodness 2021 is here. 

Each January many people have changes to their health insurance whether it’s a new health plan, changes in the amounts of deductibles, copays, and/or new drug formulary.  Since the start of the year, I have worked with several individuals with diabetes to help make their diabetes medications more affordable that experienced changes to their health insurance plans.  Even for the most well versed in health insurance, all of these changes can be overwhelming and confusing.  Here are some very practical money saving tips to consider before you head to the pharmacy to pick up your prescriptions this month: 

-Make sure that your pharmacy has your updated health insurance information

-Inquire as to whether you have lower prescription copays by getting 90 day supply as opposed to 30 day supply

-Inquire as to whether your health insurance plan has lower copay for using mail order pharmacy (I cringe typing this sentence as I am a firm believer in patient choice of their preferred pharmacy) 

-Look up your preferred drug formulary for your health insurance (****warning this change even if your overall health insurance plan did not change), and learn the preferred brand name and generic medications for the class of drugs that you have been taking 

-Always ask if cash price is less than your copay particularly for generic medications

-Check price on GoodRx as it may be lower than your insurance copay particularly for generic medications 

-For brand name drugs, check the pharmaceutical manufacturer website for copay or savings cards

-If you can not afford your medications, please talk with your pharmacist and your medical provider’s office. Please DO NOT simply go without the medication until your next telehealth or office visit.  

Brand name drug	A drug under a trademark name or specific name and is protected by a patent. For example, Lantus, Levemir (Reference: www.healthcare.gov)
Generic drug	a medication that is approved to be the same as a brand name drug specifically with regards to dosage form, strength, safety, route of administration and quality.  (Reference: www.fda.gov)
Drug formulary	a list of medications (brand and generic) covered by your health plan. Often drug formularies have tiers with least expense medications (generics) as tier 1 and most expensive as tier 3 or4).  (Reference: Goodrx.com)

I hope that this blog has provided you with tips that will prevent you from the experience of rationing or simply not getting your medications because of cost. 

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#avoiding #medication #cost #shock

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So person with diabetes presents to the emergency room due to significantly elevated glucose after rationing insulin due to recent job loss. Unfortunately this scenario happens way too often these days. It breaks my heart. I have a passion for helping people with financial resources so they can afford their medications. A resource that I use on a weekly basis is NovoCare Immediate Supply. I have provided the link below – if you are a person with Medicare Part D, please call 1-800-910-0454 to enroll. While this is not a long term solution by any ways, it can provide short term help with accessing insulin. Basically, it provides a month supply of NovoNordisk insulin (i.e. Novolog, Fiasp, Levemir, Tresiba) (pens and/or vials) at no cost. Persons with diabetes or healthcare professionals can click on the link to enroll and get the copay card. Once you have the card, simply take to the pharmacy – make sure you have a prescription for insulin.

https://www.novocare.com/insulin/immediate-supply.html

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#insulin #access #rationing

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