Posted on 04/29/2005 7:53:31 PM PDT by NormsRevenge
WASHINGTON - Type 2 diabetics got a new option to help control their blood sugar Friday, a drug derived from the saliva of the Gila monster — but one that must be injected twice a day.
The Food and Drug Administration approved Byetta, known chemically as exenatide, the first in a new class of medications for Type 2 diabetes — but for now, it's supposed to be used together with older diabetes drugs, not alone.
Makers Amylin Pharmaceuticals and Eli Lilly & Co. said the prescription drug would begin selling by June 1, but wouldn't provide a price.
Some 18 million Americans have diabetes, the vast majority the Type 2 form, in which the body loses the ability to turn blood sugar into energy because it either doesn't produce enough insulin or doesn't use it correctly. It is closely associated with obesity.
When diet and exercise aren't enough to control Type 2 diabetes, patients can try certain oral medications to lower blood sugar. The most common, drugs called sulfonylureas, spur the body to produce more insulin.
When those drugs fail, adding Byetta to them offers patients a new option to try before resorting to injections of insulin.
Byetta is the first so-called "incretin mimetic," meaning it mimics action of a hormone called GLP-1 that's secreted by the gut to spur insulin production after a meal — but only when blood sugar is high.
That's important, noted FDA metabolic drugs chief Dr. David Orloff, because other diabetes drugs spur insulin secretion even if blood sugar already is low, leading to the risk of hypoglycemia.
Byetta is a synthetic version of a protein found in the saliva of the Gila monster that works similarly to the human GLP-1.
In studies, Byetta was given in addition to sulfonylureas, another common diabetes drug called metformin, or a combination of the older treatments.
Adding Byetta triggered about a 1 percent drop in patients' A1C levels, an important measurement of blood-sugar averages, Orloff said. That's consistent with blood-sugar lowering caused by other diabetes drugs, he said.
The most common side effect was nausea. Also, patients who take Byetta with a sulfonylurea may need doses of that older drug reduced to avoid hypoglycemia, the manufacturers said.
The FDA encouraged the manufacturers to submit additional studies to show whether Byetta could eventually become a stand-alone treatment for Type 2 diabetes.
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Eli Lilly & Co.: http://www.lilly.com/
Food and Drug Administration: http://www.fda.gov/
Side effects; constant foraging for large insects, excessive basking in the sun and lizard lip development with extended use. (just kidding)
They are also in clinical trials of an extended release formula that would be injected once a week. I asked my Dr what he knew about this - so far, not much...
Google+broadband=ApparentGenius
It's all a lie. LOL
Is that Mary Beth Sweetland?
"Type 2 diabetics got a new option to help control their blood sugar Friday, a drug derived from the saliva of the Gila monster — but one that must be injected twice a day.
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The most common side effect was nausea.
YOU FIRST
So9
Nope.
Yup. I guess she volunteered for the clinic trials of the Gila Monster shots.
Very interesting.
One of the articles also gave the website for this medicine:
http://www.byetta.com/
What seems to be very interesting, is that it's actions are similar to those of natural hormones regulating insulin production.
At the Byetta website they have detailed information.
CLINICAL PHARMACOLOGY
Mechanism of Action
Incretins, such as glucagon-like peptide-1 (GLP-1), enhance glucose-dependent insulin
secretion and exhibit other antihyperglycemic actions following their release into the
circulation from the gut. Exenatide is an incretin mimetic agent that mimics the
enhancement of glucose-dependent insulin secretion and several other antihyperglycemic
actions of incretins.
The amino acid sequence of exenatide partially overlaps that of human GLP-1.
Exenatide has been shown to bind and activate the known human GLP-1 receptor in
vitro. This leads to an increase in both glucose-dependent synthesis of insulin, and in
vivo secretion of insulin from pancreatic beta cells, by mechanisms involving cyclic
AMP and/or other intracellular signaling pathways. Exenatide promotes insulin release
from beta cells in the presence of elevated glucose concentrations. When administered in
vivo, exenatide mimics certain antihyperglycemic actions of GLP-1.
BYETTA improves glycemic control by reducing fasting and postprandial glucose
concentrations in patients with type 2 diabetes through the actions described below.
Glucose-dependent insulin secretion: BYETTA has acute effects on pancreatic beta-cell
responsiveness to glucose and leads to insulin release only in the presence of elevated
glucose concentrations. This insulin secretion subsides as blood glucose concentrations
decrease and approach euglycemia.
First-phase insulin response: In healthy individuals, robust insulin secretion occurs
during the first 10 minutes following intravenous (IV) glucose administration. This
secretion, known as the “first-phase insulin response,” is characteristically absent in
patients with type 2 diabetes. The loss of the first-phase insulin response is an early
beta-cell defect in type 2 diabetes. Administration of BYETTA at therapeutic plasma
concentrations restored first-phase insulin response to an IV bolus of glucose in patients
with type 2 diabetes (Figure 1). Both first-phase insulin secretion and second-phase
insulin secretion were significantly increased in patients with type 2 diabetes treated with
BYETTA compared with saline (p <0.001 for both).
(pmol•kg-1•min-1)
bump!
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