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By Nancy Lapid
(Reuters) - Eli Lilly’s experimental insulin that is injected just once a week is as effective as daily insulin injections for maintaining blood sugar levels in patients with type 1 or type 2 diabetes, researchers said on Tuesday at the European Association for the Study of Diabetes meeting in Madrid.
In two late-stage trials, they compared blood sugar management over the course of a year with weekly injections of insulin efsitora alfa or daily injections of insulin degludec. One trial involved 623 participants with type 1 diabetes, while the other included 928 patients with type 2.
In both trials, hemoglobin A1c levels – a measure of blood sugar control over the previous three months – improved to a similar extent with efsitora and degludec.
Figuring out the right dose of efsitora was trickier in type 1 patients, however. These patients experienced more episodes of low blood sugar known as hypoglycemia with efsitora, particularly in the first 12 weeks of treatment, according to a report of the trial published in The Lancet.
"More work is needed to evaluate efsitora dose initiation and optimization" to maintain efficacy while mitigating the risk of hypoglycemia in people with type 1 diabetes, study leader Dr. Richard Bergenstal of the HealthPartners Institute in Minneapolis said in a statement.
Participants with type 2 diabetes were being newly transitioned to insulin after other medications failed to keep their blood sugar levels in the target range.
For these patients, “a once-weekly insulin has the potential to simplify dose administration and diminish barriers to starting insulin therapy by means of a reduction in injection burden,” Dr. Carol Wysham of the MultiCare Rockwood Center for Diabetes and Endocrinology in Spokane, Washington wrote in a report in The New England Journal of Medicine.
Efsitora and degludec are so-called basal insulins, intended to keep blood sugar levels stable when patients are not eating. Everyone with type 1 diabetes in the trial also used a short-acting insulin at mealtimes.
In July, Lilly rival Novo Nordisk failed to secure U.S. approval for its own once-weekly basal insulin icodec injection.
Air travel may affect insulin pumps
People with type 1 diabetes who wear insulin pumps should know that altitude changes during air travel can cause unintended insulin delivery, researchers said at the diabetes meeting in Madrid.
They recommend temporarily disconnecting insulin pumps before take-off and removing air bubbles before reconnecting them at cruising altitude.
The researchers monitored insulin delivery from 26 pumps in tests conducted in Europe’s largest hypobaric chamber, to mimic the atmospheric changes during a normal commercial flight.
The hypobaric chamber was de-pressurised during a simulated ascent and a 30-minute cruise, mimicking an airline pressurized cabin altitude of 8,000 feet. The ambient pressure was then increased during a 20-minute “descent” to ground level.
During the 20-minute ascent simulation, insulin cartridges over-delivered 0.6 units of insulin, an amount unlikely to lead to clinically significant or symptomatic low blood sugar episodes, the researchers said.
During descent period, when pressure was rising, the cartridges under-delivered 0.5 units of insulin, potentially leading to blood glucose being somewhat higher than usual.
“Whether these abnormalities in insulin delivery during flights cause clinical effects will depend on several factors, including an individual’s insulin sensitivity, food intake, and glycemic control,” study leader Dr. Ka Siu Fan from the Royal Surrey County Hospital and University of Surrey, UK said in a statement.
The researchers also simulated a sudden loss of cabin pressure such as would occur in an emergency. This could result in the delivery of 5.6 units of excess insulin, which could cause significant hypoglycemia, or dangerously low blood sugar, the researchers found.
Hydrogel could reduce semaglutide shots to once a month
An experimental drug delivery system could cut the dosing schedule for Novo Nordisk’s obesity and type 2 diabetes drugs, Wegovy and Ozempic, from once a week to once a month, French researchers reported at the Madrid diabetes meeting.
Semaglutide, the active ingredient in both drugs, would be delivered in a hydrogel that allows slow, sustained release of the drug over 1 to 3 months, researchers said.
A small dollop, known as a "depot," of the semaglutide-laden hydrogel is injected under the skin using commercially available hypodermic needles, Dr. Claire Megret from manufacturer Adocia in Lyon explained.
The gel has not yet been tested in large animals or humans.
“Our pre-clinical results demonstrate that the regular, slow release of semaglutide over one month after administering a single dose, with limited early release, is achievable,” Megret said.
“Next we will be testing the hydrogel platform in pigs, whose skin and endocrine systems are most similar to those in humans," she said, adding that clinical trials in humans was possible within the next few years.
(Reporting by Nancy Lapid; editing by Bill Berkrot)
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