Christine Blank

A once-weekly injection of dulaglutide (Trulicity) was superior in improving glycemic control in youth with type 2 diabetes (T2D) compared to placebo, according to a new study.

Silva Arslanian M.D., scientific director and principal investigator at the UPMC Children's Hospital of Pittsburgh in Pennsylvania, presented the findings of the international trial at the 82nd Scientific Sessions of the American Diabetes Association® (ADA) in New Orleans, Louisiana, June 3-7.

The research, funded by Lilly, Trulicity’s manufacturer, was simultaneously published in 

“These findings are a potential breakthrough in the pediatric diabetes space and can help address the unmet need for additional treatments available to young people with diabetes, particularly pharmacotherapeutic options,” Arslanian said in an ADA news release.

 “We are encouraged by the strong HbA1C improvements achieved, and are hopeful that a once-a-weekly medication could be a step forward for how young people are treated.”

The trial enrolled 154 patients between the ages of 10 and 18 years with T2D treated with lifestyle alone or on stable metformin with or without basal insulin. Patients were randomized to placebo, 0.75 mg dose of dulaglutide, or 1.5 mg dose of dulaglutide.

The researchers found that a once-weekly 0.75 mg or 1.5 mg dose of dulaglutide was superior to placebo in improving glycemic control without an effect on body mass index through 26 weeks. In addition, the safety of the therapy was consistent with the safety profile established in adults taking dulaglutide.

"Type 2 diabetes in youth is challenging to manage, with few approved treatment options," said Mike Mason, president of Lilly Diabetes, in a news release.

In the United States, minority populations have among the highest prevalence of youth-onset T2D in the world, Mason added. “Given this, we made an intentional effort to recruit and enroll populations commonly under-represented in clinical trials. The unmet need for effective yet convenient treatments for youth with T2D is substantial and we look forward to sharing these results with regulatory authorities as we pursue a potential new indication for Trulicity."

Originally publishe on our sister brand, 

1. Dulaglutide in youth with Type 2 Diabetes (T2D)—Results of the AWARD-PEDS randomized, placebo-controlled trial. Poster presentation. 82nd Scientific Sessions of the American Diabetes Association® (ADA). June 6, 2022. Accessed June 24, 2022.

2. Arslanian SA, Hannon T, Zeitler P, et. al. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. 

 2022 Jun 4. Online ahead of print. doi: 10.1056/NEJMoa2204601.

3. Once weekly drug helps control pediatric type 2 diabetes. News release. ADA. June 4, 2022. Accessed June 24, 2022. 

https://www.diabetes.org/newsroom/press-releases/2022/once-weekly-drug-helps-control-pediatric-type-2-diabetes

4. Lilly's AWARD-PEDS trial investigating use of Trulicity® (dulaglutide) in youth and adolescents with type 2 diabetes showed superiority in A1C reduction vs placebo. News release. Lilly. June 4, 2022. Accessed June 24, 2022. 

https://investor.lilly.com/news-releases/news-release-details/lillys-award-peds-trial-investigating-use-trulicityr-dulaglutide

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New research indicates dulaglutide is effective in improving glycemic control in pediatric patients with diabetes.

Dulaglutide effective in children with type 2 diabetes

After the United States Supreme Court overturned it’s the longstanding Roe v. Wade decision on June 24,

 retail pharmacies are experiencing a marked increase in patients looking to purchase Plan B emergency contraception and are placing limits on the medication.

Meanwhile, the American Medical Association (AMA) is encouraging the FDA to approve OTC access to oral contraceptives without an age restriction.

On Monday, CVS Health, Walmart, and Rite Aid began limiting purchases of the Plan B bills, which were out of stock or in short supply on their web sites, according to 

Although Walgreens does not have purchase limits in place currently, Fraser Engerman, senior director of external relations for the chain, told 

, the retailer is “working to restock online inventory for ship-to-home.”

“Walgreens is still able to meet demand in-store, including leveraging digital-first solutions like curbside pickup. Plan B is being shipped to our stores and also restocked online in the next day or 2,” Engerman added.

 the company has implemented temporary purchase limits to ensure equitable access, but it has ample supply of the pills in stores and online.

And according to Catherine Carr, manager of public relations and external communications at Rite Aid, “Due to increased demand, at this time we are limiting purchases of Plan B contraceptive pills to 3 per customer.”

Walmart did not respond to the publication’s requests for comment.

Meanwhile, the AMA’s new policy, adopted the policy at its 2022 Annual Meeting of the AMA House of Delegates in Chicago, June 10 to 15, is particularly timely given the Roe v. Wade ruling.

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” said AMA Board Member David H. Aizuss, MD, in a news release.

 “Access is one of the most cited reasons why patients do not use oral contraceptives, use them inconsistently, or discontinue use. Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”

There is a regulatory pathway at the FDA for converting oral contraceptives from prescription products to OTC products and a required manufacturer application for a switch is expected to be submitted before the end of 2022, AMA said.

When considering manufacturer applications, the FDA should consider that OTC birth control pills are safe and “a common-sense, science-based approach to addressing an important health equity and reproductive justice issue facing our communities,” the OCs OTC Working Group said in a recent letter

“Over 60 years of research and data show that oral contraception is safe and effective. However, due to pervasive and systemic inequities, significant barriers to access remain for communities who bear the greatest share of these inequities: people of color, particularly Black, Latinx, AAPI, and Indigenous peoples, people who live in rural areas, those working to make ends meet, immigrSants, LGBTQ+ folks, and young people,” the Working Group wrote. "Increasing access to over-the-counter birth control would allow people to make decisions with dignity and respect—about their own bodies, lives and reproductive health and well-being, including when and whether to have children.”

Although the National Community Pharmacists Association (NCPA) does not have an established position on the issue currently, “we expect to have more insight after the NCPA House of Delegates meets during our annual convention in October to install new officers and consider legislative, regulatory, or policy resolutions,” Andrea Pivarunas, director of public affairs for NCPA, told 

“We anticipate discussions among delegates around options that would support patients having the choice to access oral contraceptives at pharmacies while also having a healthcare provider readily available to consult with on subjects including possible drug interactions, choosing between the dozens of oral contraceptives available in the marketplace, and their uses beyond contraception (acne, headaches, etc.),” she added.

Representatives from the American Pharmacists Association and the National Association of Chain Drug Stores did not respond to requests for comment.

Meanwhile, the AMA “will work with expert stakeholders to advocate for the availability of hormonal contraception as an OTC medication and continue to study issues relevant to OTC access including full insurance coverage without cost sharing of an OTC oral contraceptive,” the organization said.

Originally published on our sister brand, 

Dobbs, State Health Officer of the Mississippi Department of Health, et al. v. Jackson Women’s Health Organization, et al. US Supreme Court opinion. June 24, 2022. Accessed June 27, 2022. 

https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf

Terlep S. CVS, Walmart, Rite Aid limit purchases of Plan B pills as demand surges following Roe ruling. MarketWatch. Published June 27, 2022. Accessed June 28, 2022. https://www.marketwatch.com/story/cvs-walmart-rite-aid-limit-purchases-of-plan-b-pills-as-demand-surges-following-roe-ruling-11656377178

AMA urges FDA to make oral contraceptive available over-the-counter. News Release. American Medical Association. June 15, 2022. Accessed June 15, 2022. 

https://www.ama-assn.org/press-center/press-releases/ama-urges-fda-make-oral-contraceptive-available-over-counter

OCs OTC Working Group letter to Robert Califf, FDA. April 4, 2022. Accessed June 24, 2022. 

https://ocsotc.org/wp-content/uploads/2022/05/OCs-OTC-letter_Califf_FINAL-4.4.2022.pdf

The American Medical Association is urging the FDA to approve OTC access to oral contraceptives.

Pharmacies limiting Plan B purchases after Roe v. Wade reversal

When pharmacists are helping patients fill out forms or are in counseling sessions, they should ask patients their preferred name and pronouns, said Kelsea Gallegos Aragon, PharmD,BCACP, assistant professor of Pharmacy Practice and Administration at the University of New Mexico College of Pharmacy and pharmacist clinician at Truman Health Services, during her presentation at the American Pharmacists Association 2022 Annual Meeting & Exposition. A patient may, for example, come in for hormone therapy, but do not want to use the pronoun for the sex they are in transition to currently.

Front desk and registration staff should also address patients by the proper pronouns. “If they use the wrong pronouns—called ‘deadnaming’ in the community—are they going to be happy or feel safe?” Aragon said. “They may leave.”

“We want to make sure everyone knows it is a safe place. You want to ensure that patients understand—whatever their gender, whatever their orientation—discrimination will not be tolerated,” Aragon said.

Another way to do this is by using only gender-neutral pronouns, such as “they,” and avoiding terms such as “guys” and “gals.”

Creating a safe, comfortable environment is vital, as the LGBQT community faces more health care disparities than the average population, according to Aragon. A 2015 study found that 1 of 3 transgender people have a negative experience at a medical visit, and 23% don’t engage in medical care due to fear of mistreatment. Additionally, 50% of LGBQT individuals said they had to educate their health care provider on how to provide care to them.

During her presentation, Aragon also clarified important definitions that pharmacy staff should know.

Sex is based on the genitalia an individual was born with, while gender is “much more complex,” she noted. “It’s how you feel about who you are, your internal sense of self, and how you fit into the world and society.”

“Gender non-binary” is used for individuals who may not feel like identifying as a male or a female, while “transgender” is an umbrella term for people whose gender identity and/or expression is different from cultural expectations.

Aragon also educated APhA 2022 attendees on feminizing hormones and masculinizing hormones.

Advise patients using estrogen—including estradiol, transdermal patches, and compounded creams—that they will experience softer, less oily skin; body fat redistribution (less in the center area of the body and more towards the hips); and decreased muscle mass—even if they are exercising the same amount of time.

Patients taking estrogen will also have thin or slow growth of body or facial hair and breast growth, an A or B cup at the most, Aragon noted.

Meanwhile, testosterone monotherapy adds more fat in the center of the body, which increases patient’s risks of higher blood pressure and developing diseases such as non-alcoholic fatty liver disease.

“This is a great time to talk [with the patient] about healthy lifestyle and…exercise,” Aragon added.

Aragon concluded her presentation by sharing helpful resources, including the Office of Disease Prevention and Health Promotion 

Healthy People 2020 Report on LGBT Health

National LGBTQIA+ Health Education Center

This article was originally published by sister publication Drug Topics.

Aragon KG. How to provide high quality care for LGBTQ patients. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX

Understanding gender terms and addressing patients using the right pronouns is vital to decreasing health disparities in the LGBQT community.

Christine Blank

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