Diabetes Self-Management Blog

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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Comments
  1. To preface, I currently use an insulin pump and continuous glucose monitor. During the past 6 months of using the CGM, I have found that during the first day while calibrating the CGM with actual blood glucose readings, that the reported levels are off by 20 to 30 percent. However, on day two and three, I have found usually less than 5% difference with my CGM and blood glucose readings.

    I believe a closed loop insulin delivery system is definitely in our future. I believe this type of therapy is going to help Type 1 diabetics to maintain more normal glucose control than has ever been achievable in the past. I do hope testing and trials will continue so diabetics can get closer to what a pancreas does each day for normal people and maybe lessen the responsibility we have each day.

    I would also be interested if any studies are still going on in islet cell implantation.

    Posted by Mike Cherry |
  2. I am using a continuous G. monitor because I had no idea when my BS goes low and someone hasto call 911-many times. This has been great for me and any new insulin would be great. I use Lantus once in the Am and Mova pen 3 times daily. Diabetes has run in my family, a sister died at 42 with it and 2 sisters have it, so I am always looking for anything new.

    Posted by Ada Rayn |
  3. I am using Novolog (formerly using Apidra) 3 to 4 times a day on a sliding scale and Lantus twice a day. BG testing is with the OneTouch Ultra2 four to five times a day, more as indicated by hyperlgycemia or hypoglycemia. I was diagnosed Type 1 with acute onset in 1970, so 40 years have given me experience with many of the emerging technologies and insulins.

    I am going through the red tape with Medicare, MedicareComplete and my HMO to obtain an insulin pump to help with long-term swings in BG that despite agressive BG testing and ICT. My Diabetologist’s first choice, the Insulet Omnipod, is unfortunately not covered by Medicare or my HMO, so we are researching an alternative pump that will be covered.

    I am going through the same “Prior Authorization” rigamarole and bureaucracy with a Continuous Glucose Meter ordered by my Diabetologist over six months ago. After 40 years duration I have acquired hypoglycemia unawareness, with nocturnal severe hypoglycemia which for serveral incidents required intervention and/or Glucogon injections by others. In one episode I became comatose, requiring a house visit by a physician 20 km away for a Glucogon injection and ambulance transport to Galway, 35 km away from the small village I was visiting in western Ireland.

    I keep Glucogon with me at all time next to my meter and insulin pens.

    I am more than ready for an insulin pump and CGM. I also feel that we are — or should be — close to a closed loop pump system and would volunteer for clinical trials.

    We also need to keep the Health Care Reform Act as well as expedite and simplify the Medicare process for insulin pumps and CGM.

    Posted by John Conrod |
  4. I’ve been a Medtronic pump user for many years and would love to have a CGM; however, Medicare doesn’t cover it. I know from my Endocrinologist that Medtronic is testing an artificial pancreas in Europe. I love the idea and look forward to its implementation in the U.S.

    Posted by Will Ryan |
  5. I am a type I who does not use a pump. I test BG usually about 5-7x daily, and take Lantus once and humalog before meals. After almost 30 years of this my fingers and test sites are sore, and I would love an alternate form of insulin delivery. However, I have a hard time with the idea of anything doing the dosing for me, because I fear mechanical failure. At least with an injection I know what I drew up and that it was put in. So perhaps the inhaler, if it is not too cumbersome to use and carry around, would be good. Can it be used for some doses during the day and injections for other doses?

    Posted by Vicki |
  6. I have med benefits that cover the insulin pump 100% but does not cover the continous blood glucose monitor or test strips.It costs me $50. for a 10 day supply.I figured out that the CGM cost very much but after the original costs it costs me less to test my blood sugar.What ever the benefits don’t cover can be deducted from income tax here in Canada.

    Posted by Eva Walker |
  7. I’m not sure the term “bioidentical” is appropriate since bioequivalency tests were never undertaken on synthetic insulin products or analogues. Regulators and doctors generally use the term “biosynthetic” which is more appropriate. Regardless, these innovations nevertheless fail to address the key efficacy failure of all insulin products on the market today: none are delivered physiologically based on plasma blood glucose levels, and all can cause hypoglycemia. While artificial pancreas products would provide significant improvement over current delivery methods, there is a “money is no object” perspective of the developers, when as many as 3 million Americans with diabetes lack any sort of insurance coverage, and it is estimated that as many as 40% of those who do have coverage still have very high deductible plans (and the incidence is growing as healthcare costs have not been contained). The product which may be the most promising was not even addressed, yet could be as close to commercialization as an “artificial pancreas” given the FDA’s approval pace for new devices relative to new drug applications, namely glucose-responsive insulin known as “SmartInsulin” which was acquired by Merck a year ago. While Merck has not disclosed where this product stands since acquiring SmartCells, Inc., we could theoretically see Phase I trials begin as soon as 2013.

    Posted by Anonymous |
  8. I would love to try a CGM. Want to use a pump, but have worried about the size and infections. Very interested in something that could monitor glucose and control with meals. Sounds extremely promising.

    Posted by anonymously |

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