Life with diabetes usually involves lots of injections of insulin, the hormone that controls blood sugar. Recent research investigating a once-weekly vaccine finds it may help lessen the burden for some with the disease.
Two pharmaceutical companies have developed weekly insulin formulations and tested the drugs in late-stage clinical trials. This September, in New England Journal of Medicineresearchers reported promising results for efsitora, from Eli Lilly. For adults with type 2 diabetes, the drug worked like a once-daily insulin formulation. But a trial of adults with type 1 diabetes was reported in the same month in Lancetfound that there were more episodes of dangerously low blood sugar in the group taking efsitora than in the group taking a once-daily insulin.
Meanwhile, icodec, from Novo Nordisk, has received approval for use in adults with diabetes from the European Union and from Canada and several other countries. But the US Food and Drug Administration announced in July that it is not ready to approve the company’s application for icodec. In May, an FDA advisory committee had voted against moving the drug forward in part because of safety concerns over the increased risk of hypoglycemia — the clinical term for blood sugar that is too low — for those with type 1 diabetes.
It will likely take time before things shake out on whether, when, and for whom weekly insulin will become available in the United States. At present, clinical trials provide some insight into the utility and limitations of a weekly formulation. Scientific news spoke with two experts about weekly insulin, what’s challenging about trying to mimic the body’s system for regulating blood sugar, and what else would be helpful for people managing diabetes.
What is diabetes and how is it treated?
Diabetes develops when blood glucose levels become too high because the body has lost the ability to properly regulate this sugar – the body’s main fuel – with the hormone insulin. Type 1 diabetes is an autoimmune disease that destroys the cells in the pancreas that produce insulin. With type 2 diabetes, these cells do not produce enough insulin or the body does not respond to insulin effectively, or both. Over time, high blood sugar levels can damage the kidneys, heart, eyes and nerves.
About 38 million people have diabetes in the United States, roughly 12 percent of the population, according to the US Centers for Disease Control and Prevention. About 2 million of them have type 1.
Managing diabetes means monitoring blood sugar levels throughout the day and, for those with type 1 and some with type 2, figuring out how much insulin to take. If the insulin dose is too high, the blood sugar drops too much. Effects can be felt quickly and can include tremors, nausea, fatigue, hunger, dizziness and irritability, among other symptoms. If blood sugar levels drop too low, a person can become confused, feel weak, have trouble walking, and even lose consciousness. Severe hypoglycemia is a medical emergency.
With diabetes, there’s “a lot of thinking about food and about numbers,” says Laura Young, an endocrinologist specializing in diabetes care at the University of North Carolina School of Medicine at Chapel Hill. “She never stops.”
People with type 1 and some with type 2 may face multiple daily insulin injections. Short-acting insulin covers the rise in glucose that comes with meals. Long-acting insulin that lasts about 24 hours manages the time between meals and overnight. Covering three meals and the rest of the day and night adds up to “at least four meals, and that’s probably the minimum,” says Young.
How does the body normally regulate blood sugar and why is this difficult to duplicate?
Special cells in the pancreas, called beta cells, produce insulin (SN: 12/11/07). Beta cells detect the amount of glucose in the blood and secrete the required amount of insulin, responding to changes in glucose due to meals, exercise, illness and stress. In the body, there’s “constant regulation to keep sugar in a good range, even if we’re not eating,” says endocrinologist Giulio Romeo of Harvard Medical School and the Joslin Diabetes Center in Boston. “It’s hard to replicate our body’s ability to fine-tune” this process, says Romeo.
Insulin injections cannot mimic the beta cell response. How quickly an insulin is absorbed into the blood depends on where the injection is made. And while researchers have made innovative chemical modifications to insulin formulations, creating versions that last for 24 hours or more, long-acting insulins are unable to provide the same stable glucose management between meals that cells can. beta.
Instead, there are small rises and falls as the long-acting insulin is released, Romeo says. This means that there may be a little more or less insulin available over time. Plus, once a dose is taken, “you can’t change it,” says Romeo. If a long-acting dose turns out to be more than needed for the next 24 hours, a person may end up with low blood glucose levels.
How will once-weekly insulin be used?
Once-weekly insulin is intended to take the place of a once-daily long-acting vaccine. It can make a difference to people’s quality of life “having to take one less shot a day,” says Young. But the main thing will be “making sure it’s the right dose,” she says. With a once-daily injection, if the dose is too high, “it’s much easier to deal with hypoglycemia for that period of time versus the whole week.”
In clinical trials of two weekly formulations, there were more episodes of severe hypoglycemia in participants with type 1 diabetes who received insulin once weekly compared to those who received it once daily. This was not a problem with trials of participants with type 2 diabetes.
People with type 2 diabetes “still make some of their own insulin,” says Young, and “for the most part, have less variability in their blood sugar” than people with type 1 diabetes. This can reduce the risk of ending up with hypoglycemia. Weekly insulin “is certainly promising” for type 2 diabetes, she says. For type 1, “I think they’re going to have to show some more data and be a little more precise” about what people with type 1 might benefit from, she says, in terms of blood sugar variability. and other factors.
It’s harder to make the necessary adjustments “when you’re committed to a medication that’s injected once a week,” says Romeo. “I think people with type 1 need some level of daily regulation that makes weekly insulin probably not the best option overall.”
What other health care improvement would help people manage diabetes?
“The affordability of continuous glucose monitoring systems is really key,” says Romeo, to help expand access to these devices. Continuous glucose monitors read blood sugar levels 24 hours a day via a sensor placed under the skin. Without this technology, people test for glucose by pricking their finger for drops of blood several times a day. Using continuous glucose monitors to manage diabetes can reduce hospitalizations and improve quality of life for those on intensive insulin schedules. But it can be difficult to meet the eligibility requirements insurance companies set to get coverage for the devices, which can cost several thousand dollars out of pocket.
Young wants more people to access and benefit from diabetes education, which includes how to monitor blood sugar, how to inject insulin, understand the impact of activity and different foods on blood glucose, and more. A study published in 2022 found that only half of adults with diabetes reported receiving diabetes education. Those who did were more likely to take steps to manage their diabetes and receive clinical care than those who did not. Diabetes education “seems a little old-fashioned,” Young says, “but it’s really important.”
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