Getting to one injection a week will be a huge advance in diabetes treatment. Today we have one product being considered by the FDA, and one in advancing clinical trials. And, of course, we have other continuing news on treatments and consequences
Healthy Returns: Eli Lilly, Novo Nordisk are competing to develop more convenient weekly insulins
Novo Nordisk
Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people with type 2 diabetes in ONWARDS 5 phase 3a trial
The ONWARDS 5 trial was a 52-week, open-label efficacy and safety treat-to-target trial investigating once-weekly insulin versus once-daily basal insulin (insulin degludec or insulin glargine U100/U300) in 1,085 insulin-naïve people with type 2 diabetes in a clinical practice setting including fewer trial visits compared to the other ONWARDS phase 3a trials.
In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 0.19 events per patient-year exposed to once-weekly insulin icodec and 0.14 events per patient-year exposed to the once-daily basal insulins. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials evaluating once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using insulin for the first time (insulin naïve) and those who require multiple daily insulin injections. In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally.
Lilly has not submitted Efsitora to the FDA for approval.
Other News
Fierce Pharma
Dexcom report finds that living with Type 2 diabetes leads to anxiety, depression at 'alarming' rates
A new survey from Dexcom suggests living with Type 2 diabetes can have significant impacts not only on physical health, but on mental health, too.
Even after diagnosis, just over a quarter of patients and caregivers surveyed still haven’t been properly educated about proper nutrition to help manage diabetes.
That lack of education about Type 2 diabetes has led to difficulties managing the condition for many, including nearly two-thirds of those surveyed, who cited ongoing challenges with their diets and mental health. Common concerns among newly diagnosed patients, according to the clinicians surveyed, include worries about long-term complications, diabetes-related health issues and the impact on their daily lives.
In a related statistic, the report found that 42% of patients and caregivers said the condition has had a negative impact on their mental health or that of the person they care for. The most common of these effects are anxiety and depression, affecting 61% and 52%, respectively, of those who reported a mental health impact.
CBS News
High cost of drugs like Ozempic a struggle for lower-income patients
Rising prices, insurance hurdles and a supply shortage can make access difficult for people who rely on drugs like Ozempic for diabetes.
CBS News
High price of Ozempic, other diabetes drugs deprive low-income people of effective treatment
For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill their prescriptions for the medications they need to control their blood sugar.
Reuters
Lipid nanoparticle-mRNA regimen reverses inflammation and aids recovery from diabetic wounds in mice
Researchers at the Icahn School of Medicine at Mount Sinai have designed a regenerative medicine therapy to speed up diabetic wound repair. Using tiny fat particles loaded with genetic instructions to calm down inflammation, the treatment was shown to target problem-causing cells and reduce swelling and harmful molecules in mouse models of damaged skin.
Details on their findings were published in a paper titled "Accelerating diabetic wound healing by ROS-scavenging lipid nanoparticle-mRNA formulation" in the May 20 online issue of the Proceedings of the National Academy of Sciences.
The paper is paywalled.
Clinical trials next.
I could have done with that treatment this last year. My father had non-healing foot sores, partly due to being a Christian Scientist and not taking insulin, more than 50 years ago. His doctors wanted to amputate both of his feet, but he recovered with insulin and prolonged bed rest. The Church sometimes allows members to take medicine in emergencies.
Personal Notes
I am going off long-acting Toujeo, and starting rapid-acting Humalog/Insulin Lispro 100 Unit/ML Pen. Toujeo takes hours to bring my glucose down if I eat high-carb food, and Lispro should be much faster.
Insulin lispro is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.
I will have to experiment on myself to find out what doses would be appropriate with my glucose at various elevated levels (titration). My pharmacy is going around with my insurance and my doctor to fill this new prescription for the first time, and has stated that I should get it on May 29.
I was having a problem up until last week with frequent episodes of hypoglycemia, about every other day. I greatly tightened up my use of my CGM last week, not waiting to get below 70 to take glucose or other carbs, but starting at 90. So no hypoglycemia this week, and no taking too much glucose or carbohydrate, and overshooting upward. I can eat a small potato, or maybe two cookies, or a bit of chocolate, and stay in bounds at both ends. Mostly.
