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March 29, 2011
Insulin therapy for diabetes has undergone countless changes since it became available as a commercial treatment in 1923 — from the development of longer-acting insulin in 1946, to the marketing of bioidentical human insulin starting in 1983 (before which all insulin came from cows and pigs), to the introduction of fast-acting insulin analogs in 1996. These developments, along with many others — from blood glucose meters to insulin pumps — have proved to be durable contributions to insulin therapy that have improved the lives and health of many people with diabetes. And, of course, this pattern continues, with new forms of insulin and insulin delivery systems constantly in development.
Not all innovations catch on, though, and even those that become mainstream treatments may not be not right for everyone. Here’s a look at some still-in-development insulin treatments that have recently made the news:
A new long-acting insulin developed by Novo Nordisk, called insulin degludec, was found in a study released earlier this month to be effective in people with Type 2 diabetes in doses given just three times a week. Published in the journal The Lancet, the study enrolled 245 participants with an HbA1c level between 7% and 11% who already took an oral diabetes drug. They were assigned to one of four groups for 16 weeks: One group received insulin degludec three times a week, two groups received different starting doses of insulin degludec once a day, and the final group received insulin glargine (brand name Lantus) once a day. As an article on WebMD notes, at the end of the study, the average HbA1c level in each group was similar: 7.3% in the three-times-a-week degludec group, 7.4% and 7.5% in each of the once-a-day degludec groups, and 7.2% in the glargine group. But taking insulin degludec daily may offer an advantage; of those participants who did, only 5% experienced hypoglycemia, compared with 13% of those who took either insulin degludec three times a week or insulin glargine once a day.
In January, the quest by MannKind Corp. to introduce a new inhaled insulin to the market — after the commercial failure of Pfizer’s Exubera — hit a roadblock when its insulin product, Afrezza, was rejected by the US Food and Drug Administration (FDA). The product is not yet dead, however — according to a Reuters article, the FDA requested two new clinical trials of Afrezza to make sure that its second-generation inhaler device works as well as a first-generation device used in earlier trials. Both of Afrezza’s inhalers are much smaller than the much-maligned Exubera inhaler; while that inhaler was often compared to a bong, Afrezza’s has been compared to a whistle. As Diabetes Flashpoints noted last year, Afrezza has other advantages over Exubera, including an ultra-fast peak of action: 12–15 minutes after inhalation. Exubera’s action peaked 45–60 minutes after inhalation, and currently available rapid-acting insulins (lispro, brand name Humalog; aspart, brand name Novolog; and glulisine, brand name Apidra) tend to peak at least 30 and as many as 90 minutes after injection.
Finally, earlier this month the Journal of Clinical Endocrinology & Metabolism published a study that tested an experimental closed-loop insulin delivery system — what many people refer to as an “artificial pancreas,” the combination of a continuous glucose monitor with an insulin pump in which a computer program (rather than a human) adjusts the rate of insulin delivery based on glucose readings. The study was small, involving eight adult participants with Type 1 diabetes; and short, lasting 30 hours. The system was found to be generally effective at controlling participants’ glucose levels, with average fasting glucose after one day on the system at 118 mg/dl, close to the target of 110 mg/dl. Participants’ glucose levels averaged 132 mg/dl two hours after breakfast on the second day and stabilized three to four hours after breakfast at 97 mg/dl, close to the target of 90 mg/dl. However, three of the eight participants required extra carbohydrate at breakfast to prevent hypoglycemia. Many more studies and refinements will be needed before a closed-loop system is developed that can safely and effectively control blood glucose outside of a medically supervised setting.
How do these innovations sound to you — would you be interested in a long-acting insulin that requires injection only three days a week; in an inhaled rapid-acting insulin; or in a closed-loop insulin delivery system? Why or why not? Do you believe that each of these innovations will ultimately succeed or fail to gain popularity as a diabetes treatment? Leave a comment below!
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