Ahithophel Weissberger

Mannkind: Overlooked Biotech With Excellent Prospects (Part V)

User 213006:
"Your claims about Byetta are patently false. Here's on example: take a look at the label. RESTORING first phase insulin response is in the label." -- User 213006

You are correct that on page 2 of the Byetta prescribing information, it states that Byetta restores the Phase 1 insulin spike, with an accompanying chart from a study as a source. (For all those who want to read it themselves, Byetta's prescribing information can be found at pi.lilly.com/us/byetta...)

However, if you look at it carefully, you will see that the chart and caption describe giving Byetta at a constant level through an IV tube and then adding glucose through an IV tube. This is not the way Byetta is actually taken by patients. Patients inject themselves twice a day, within 60 minutes before their morning and evening meal. On page 3 of the prescribing information, it says that the average time for Byetta to peak in the blood is 2.1 hours after injecting. That makes the information on page 2 about Byetta through IV irrelevant to the use of Byetta in real life. We have to see what the sudies from the actual clinical trials, where the patients were taking Byetta normally, show about the Phase 1 insulin spike.

I have located one such study for you. It can be found at care.diabetesjournals.... The part that interests us now is on Page 4 Chart C. This chart shows the insulin levels on the last week of the trial. The patients took Byetta at 0 minutes, ate the standardized meal at about 15 minutes, and had their insulin levels monitored for around 3 hours. As you can see by eyeballing the chart, there is nothing resembling the Phase 1 insulin spike. Instead, insulin levels rise steadily until it peaks around 1 hour after injection, which is just about the same as the peak for conventional injected insulin. The healthy body which DOES have a Phase 1 insulin spike, peaks its insulin levels within 10 minutes.

I've been sifting through more medical journals to see if I can find more information on the topic and have come up blank so far. But as of now, I don't think that I made a mistake.

If you have any more questions on my article, please feel free to ask them.