Friday’s Daily Piece: Dapagliflozin’s DAPA-CKD Results Led to FDA Breakthrough Therapy Designation for Chronic Kidney Disease

The results of the clinical trial, DAPA-CKD, which studied dapagliflozin (Farxiga) in adults with chronic kidney disease with or without type 2 diabetes on, has led the way for the FDA giving dapagliflozin breakthrough therapy designation (BTD) for adults chronic kidney disease with or without type 2 diabetes. Breakthrough therapy designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 

To learn more about the findings of DAPA-CKD and the newly earned BTD, please click on links below.

https://www.healio.com/news/endocrinology/20200924/dapackd-dapagliflozin-prolongs-survival-in-ckd-with-without-type-2-diabetes?M_BT=4557970002905

https://www.healio.com/news/endocrinology/20201002/dapagliflozin-earns-breakthrough-therapy-designation-for-ckd-with-without-type-2-diabetes?M_BT=4557970002905

4 Main Complications From Farxiga | by Terry Crane | Medium
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#CKD #diabetes #FDA #dapagliflozin

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Friday’s Daily Piece: FreeStyle Libre 3 is on the Horizon

Exciting technology news to share…as is often the case, diabetes technology is approved in Europe before being approved in the U.S. FreeStyle Libre 3 has been cleared in Europe for those four years of age and older. My favorite aspects of this newer version are NO scanning and much smaller size. So FreeStyle Libre 3 is truly a real time CGM (on demand). It will be a bit of time before U.S. approval however we know it is on the horizon. Now, on a side note, we must continue our advocacy effects for access to technology for persons with diabetes.

FreeStyle Libre 3: World's Smallest Sensor is Here | Abbott Newsroom

Abbott Pushes CGM Boundaries with Freestyle Libre 3 | mddionline.com
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#Libre #CGM #realtime #diabetes

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Friday’s Daily Piece: Novel Once Weekly Insulin As Safe and Effective as Daily Insulin Glargine

A novel once weekly insulin, insulin icodec, (an experimental basal insulin analogue) was found to be as safe and effective as once daily insulin glargine in a Phase 2 trial. No study participants had previously received long term insulin treatment. The 250 study participants were on metformin with or without a DPP-IV inhibitor, and with hemoglobin A1c (A1c) above 7%. A similar drop in A1c was seen in both groups as well as both groups had low incidence of clinically significant or severe hypoglycemia. To learn more, please click below.

https://www.medpagetoday.com/meetingcoverage/easd/88759?xid=nl_mpt_DHE_2020-09-23&eun=g1137305d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-09-23&utm_term=NL_Daily_DHE_dual-gmail-definition

https://www.nejm.org/doi/full/10.1056/NEJMoa2022474?query=pfw&jwd=000020040769&jspc=

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#novel #diabetes #weekly #insulin

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Wednesday’s Daily Piece: Empaglifozin Fast Tracked by FDA

Empagliflozin, Jardiance, has been fast tracked by FDA for reducing death and preventing hospitalization for heart failure in adults with or without diabetes with a previous heart attack.

Empaglifozin trial, EMPACT-MI study, is studying the effect of the drug on all cause mortality (death) and hospitalization for heart failure in adults with or without the diabetes who had a heart attack or history of chronic heart failure. This study is part of a large program, EMPOWEER clinical program, which is studying the impact of empagliflozin on the spectrum of cardiac (heart), renal (kidneys), and metabolic (i.e. diabetes) conditions. This makes perfect sense as diabetes does not occur in a silo but rather with heart, kidney and other metabolic conditions.

To learn more, please click below.

https://www.healio.com/news/endocrinology/20200915/fda-fast-tracks-empagliflozin-for-reduced-allcause-mortality-hf-hospitalization-risk?M_BT=4557970002905

Jardiance May Help Heart by Shifting Its Fuel | MedPage Today
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#empagliflozin #FDA #fast-track

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Tuesday’s Daily Piece: Extension of Lilly’s $35 Copay Card Program

The $35 Lilly insulin copay card program introduced a few months ago after COVID began is being extended. What makes this card different? It provides $35 copay for insulin for persons without health insurance or with commercial insurance (state or federal heath insurance programs are not included in this copay program). The program covers most Lilly insulin products and all insulin lispro (Humalog) U-100 formulations. Please click below for more information.

https://www.insulinaffordability.com/

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#insulin #copay #Lilly

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Thursday’s Daily Piece: Dulaglutide Higher Doses Approved

FDA has approved higher doses (3 mg and 4.5 mg) of dulaglutide based on data from the AWARD-11 trial. So what does this mean for the person with diabetes? We now have additional dosing options for dulaglutide which provide greater reduction in hemoglobin A1c and weight. My only potential concern is increased incidence of nausea with these higher doses. These new doses of dulaglutide will be available in pharmacies later this month. For more details, please see the two links below.

https://diatribe.org/fda-approves-higher-doses-trulicity-help-people-type-2-diabetes

https://www.healio.com/news/endocrinology/20200904/fda-approves-larger-dulaglutide-doses-for-type-2-diabetes?M_BT=4557970002905

Trulicity 3mg, 4.5mg Approved for Type 2 Diabetes - MPR
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#dulaglutide #diabetes

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Thursday’s Daily Piece: Diabetes Technology Update – Expanded Coverage and Age Indication, and New Option

I absolutely love diabetes technology and feel strongly that all persons with diabetes should have access CGM as well as when on basal bolus insulin regimen access to insulin pump. Some good news this week with regards to a new system, and expanded indication and coverage.

  1. MiniMed 770G system, Medtronic’s latest hybrid closed loop system is now FDA approved for ages 2 and older.

2. FDA has expanded age indication for Freestyle Libre 2 as the system is now approved for ages 4 and older.

3. Medicare has expanded coverage for Freestyle Libre 2, an integrated CGM system. For more details, please click below.

https://www.healio.com/news/endocrinology/20200901/medicare-to-cover-integrated-cgm-system-for-beneficiaries-with-diabetes?M_BT=4557970002905

Abbott gets CE Mark for Freestyle Libre 2, adds Bluetooth for real-time  alerts | MobiHealthNews
Hot New Technology from Medtronic Diabetes
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#technology #Medtronic #Libre2

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Wednesday’s Daily Piece: Professional Continuous Glucose Monitoring (CGM) Avenue for Glucose Pattern Insight

I love using technology particularly CGMs as it provides insight for both the person with diabetes and healthcare professional on the patterns in the glucose and assessing the factors (there are SO many!!) that impact the glucose. Unfortunately, not all persons with diabetes have access to personal CGM at this time. An alternative that I have found to be very helpful is the professional CGM. So what is the professional CGM?

I have found the professional CGM to be particularly helpful for persons with diabetes who do not currently have personal CGM and would like to have more insight into their glucose patterns.

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#diabetes #professional #CGM

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Thursday’s Daily Piece: Canagliflozin Loses Leg and Foot Amputation Boxed Warning

Well, a new bright day has dawned for canagliflozin. Canagliflozin has had a boxed warning for leg and foot amputations. FDA review of new data from three clinical trials resulted in the removal of the boxed warning for leg and foot amputations. Additionally, canagliflozin is now recognized for its heart and kidney related benefits. To learn more, please click on the link below.

https://www.fda.gov/safety/medical-product-safety-information/invokana-invokamet-invokamet-xr-canagliflozin-medwatch-safety-alert-boxed-warning-about-risk-leg-and

INVOKANA® (canagliflozin) Significantly Reduced Major Cardiovascular Events  and Kidney Failure in Patients with Type 2 Diabetes and Chronic Kidney  Disease – Intelligence Pharma
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#canagliflozin #FDA

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August Blog: Insulin…Really??!!

Cindy, a 52-year-old female who has had type 2 diabetes for the past10 years, is preparing herself for an upcoming office visit with her primary care provider.  She feels both anxious and guilty for not better managing the day to day needs of having diabetes as well as she would like to do. Like so many others living with diabetes, life gets in the way.  Diabetes has become another “to-do” item on her daily list that makes her pull the sheets back up over her head each morning – fighting to get started.  Cindy wonders out loud, “am I alone?”  Lately, she has been afraid to check her glucose assuming in advance it will be “bad.” 

The day arrives for her office visit and she thinks, “okay, I can do this.” The visit begins and she waits in anticipation for the “finger stick” to get her hemoglobin A1c and glucose check.  The finger stick is not too bad this time.  As her primary care provider enters the room, she is friendly and shows genuine concern for Cindy.  Her provider shares her glucose is 300 mg/dL and hemoglobin A1c is 10%.  What??!! How could it be??!! She has taken her three oral diabetes medications (metformin, glipizide and sitagliptin) almost all of the time.  She begins to cry as a wave of guilt, exhaustion and shock overcome her.   Her provider reassures her and allows her time to let her tears fall. After a few minutes, they have a discussion of next steps.

Cindy is not alone. Many people are living the high demands of day to day life events while managing the daily realities of diabetes self-care.   Unfortunately, for persons with type 2 diabetes, for far too many years, insulin was used as a weapon of intimidation and a tool to threaten “compliance” to diabetes self-care.  Today, we have made much progress in the understanding of diabetes and know that insulin as a medication is part of the process for many persons with diabetes – especially those with insulin deficiency.  Those with type 2 diabetes requiring insulin medication have done absolutely nothing wrong, rather their body has lost the ability to make sufficient amounts of insulin to support insulin demands of the body.  Yes, more work is essential to remove the stigma of insulin therapy for persons with type 2 diabetes.  

As it turns out, Cindy’s provider ordered a c-peptide (a test that measures the body’s ability to produce insulin) to further assess CH’s ability to produce insulin.  Her c-peptide result was < 1 ng/mL indicating her body cannot produce sufficient insulin to match her body’s needs.   Also, her provider ordered a professional continuous glucose monitor so together they can see the trends in her glucose over a fourteen-day period to determine the most appropriate lifestyle changes and insulin regimen.

In the meanwhile, Cindy and her provider together develop a medication regimen which includes insulin and a couple of additional medications to match her body’s needs.  Before leaving, her provider schedules Cindy an appointment with the diabetes care and education specialist to provide ongoing support and education for her.  On the way out, Cindy meets her diabetes care and education specialist who greets her with a warm hello, words of encouragement, her business card, and asks her to call prior to her appointment if she gets overwhelmed with her diabetes.

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#insulin #diabetes #stop #shame

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