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June 4, 1999

Insulin Analogs

Question from Toronto, Ontario, Canada:

My son just turned 6 years old and was diagnosed at 16 months of age. His numbers have always been erratic (mostly with highs) and his HA1c results have been in the high range (between 9 and 11). His numbers at lunch and dinner are usually perfect (between 4.0 mmol. and 8.0 mmol.), but his night time numbers have been high as have his morning numbers. We tried extra insulin, but that often causes lows. As a prime example, we bumped up his N and R the other day a little, and for God knows what reason I had a sick feeling and checked his finger at 3 A.M. His blood glucose was 1.3 mmol. and I immediately woke him giving him juice and cookies. The diabetes nurses assured us that if he had a low during the night he would wake up or rebound. But obviously being 1.3 mmol. and not feeling low nor waking up, this must be a myth. I have also read a couple of stories of children who have gone to sleep and not waken up.

Anyways, I digress. My son’s endocrinologist is suggesting we switch to Humalog instead of R (at least at bedtime), as this would leave his system quicker and reduce the risk of hypoglycemia during the night. I noticed, however, that Humalog is not recommended by the FDA for children under 12 (I don’t know Health Canada’s opinion), and I also noticed that some people claim it has side effects like severe tics.

I am also wondering whether animal insulin might be a better solution. From newsgroups I belong to and people I have spoken to, many swear by pork or beef/pork insulin. Apparently the curve of these insulins isn’t as severe as “human”, and from what they tell me, they have much stronger warning signals. Someone even went so far as to point out to me that the number of deaths has increased substantially since the introduction of human insulin and that Humulin is on the FDA’s list of the world’s most deadly drugs.

I realize that the drug companies want to take the animal insulins off the market, but if they are safer than human and if they are better in warning of hypoglycemia, I’m thinking this may be the solution.

What is your opinion?


From: DTeam Staff

I think that I can help best by assuring you first of all that your fears of Humalog and other semisynthetic human insulins are unfounded. It is true that it is still not ‘officially’ recommended for young children; but that is because of the enormous costs of the full official clinical trials needed for FDA approval. In fact this insulin has been widely used in this age group in both North America and Europe and there have been many publications in reputable Journals that attest to its safety. The product also has the very important property that its action is rapid, beginning in ten minutes and completed within four hours. This means that each dose can, with experience, be adjusted to the pre-meal blood sugar and appetite and the insulin can then be given right after the meal. It can also if necessary be mixed with regular insulin to adjust the duration of activity. The high morning blood sugars are in all likelihood the consequence of a rebound from the very low early morning blood sugars.

I believe quite strongly that the advice to ignore these because your son did not wake was incorrect and that you need with the help of his endocrinologist to devise a regimen that reduces insulin activity at this time. First of all, it might be a help to take enough blood sugars to enable you to decide whether there is any link between nighttime hypoglycemia and vigorous exercise in the preceding afternoon. It would also be a help to know if increasing the amount and protein content of the bedtime snack would avoid the hypoglycemia. In any case I think that the advice to change to Humalog for the evening dose is both safe and well advised. It should help control the high bedtime values and avoid the early morning hypoglycemia. These changes in turn should lead to better overall control and a lowering of A1c levels to nearer the upper levels of normal.

Additional comments from Dr. Quick:

I must add to the reader that I am unaware of any tics from Humalog; that animal insulins are not intrinsically better than human; and that the scare stories such as are repeated here about deaths and FDA 10-most wanted lists are difficult to reconcile with the huge improvements in both lifestyle and medical care that the new insulins have allowed for people with diabetes.


[Editor’s comment: Regarding your comment about Humulin being on the list of the FDA’s most deadly drugs, I suspect the reference is to the Annual Adverse Drug Experience Report: 1995 in which Humulin insulin appears eighth in a list of the top ten reported drugs (see page 10 of the report). The report does not indicate what type of problem people reported, just that 1,988 reports were filed.