Diabetes News
Week of May 14, 2000 |
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Diet Pill Controls Type 2
For those with Type 2 diabetes, problems with weight can
often be a major contributor to the development of their
disease. According to a recent study, one diet pill can help
people to lose weight as well as control or even prevent
diabetes.
In a new issue of the Archives of Internal Medicine,
researchers published the results of their study with the drug
orlistat, commercially known as Xenical. They found that obese
people with Type 2 who took the medicine not only lost weight,
but also stabilized their blood sugars.
The study included 700 obese people in the US and in Europe.
Participants adopted a low-calorie diet, exercised, and took
120mg orlistat or a placebo three times a day for two years.
People who were taking the orlistat lost about 15 pounds,
compared with the 8 pounds lost by people taking the placebo.
Also, 72% of those who were taking orlistat and who had high
blood sugar levels regained normal blood sugar levels. This is
compared to the 49% of people who regained normal blood sugars
while taking the placebo.
Researchers also saw connections between taking orlistat and
preventing the onset of diabetes. Of the people in the study who
had problems processing glucose, only 3% of people taking
orlistat went on to develop diabetes, while 8% of those taking
the placebo developed the disease.
Mini-Pump Now Available
For those with Type 1 diabetes, insulin pumps may seem
annoying and even confining, since they are worn at all
times. Users may also feel that they are potentially stigmatized
by others who become too aware of their condition by observing
thier pump. One company is seeking to change the comfort level
and image of pumps, and
has done so by creating the smallest pump ever.
Disetronic Medical
Systems, Inc. has created the Dahedi
pump, which is about two-thirds the size of other pumps
on the market. The Dahedi pump has been available in Europe for
several years, and is now available in the US. More information
is available on the website, or by calling 877-6-DAHEDI.
Pain Relief With New Drug
Some people with neurological damager resulting from diabetes
experience pain
throughout the day, and even more so at night. A study presented May 2nd at the annual
meeting of the American Academy of Neurology, San Diego, CA. provides hope for
living pain-free with diabetes.
About half of the 15.7 million Americans with diabetes
experience some nerve damage according to the American Diabetes
Association. For many of these people the damage is asymptomatic
but damaged nerves can intensify
pain transmission in the central nervous system, and release
excessive amounts of glutamate. This in turn increases the
action of N-methyl-D-aspartate (NMDA) receptors in cell
membranes so that toxic levels of calcium enter the neurons.
Currently, the FDA has not approved any particular drug to
fight neuropathic pain. The drug company Neurobiological
Technologies, Inc. hopes to change that with their drug
Memantine, which acts as an NMDA-blocker. They recently
conducted an eight-week study of about 500 people, who were
divided into a group taking 40 mg of Memantine, a group taking
20 mg, and a group taking a placebo.
Among those taking 40 mg of the drug, 44% experienced a 50%
reduction in pain. This was compared to the 29% of the placebo
group who had similar results. There was no significant
difference between those taking 20 mg of the drug and those
taking the placebo.
The report from the study has been submitted for peer review
to the journal of the American Academy of Neurology. The next
step will be to conduct a study to compare the 40-mg dosage with
a placebo in an additional 500 people. Right now, Memantine is
used by many people in Europe as a treatment for dementia and
other neurodegenerative problems.
GlucoWatch Closer To FDA Approval
When people need to monitor their blood glucose levels many
times a day, the news that a non-invasive device that does this automatically is
close to market is very
exciting. The FDA has just released an "approval
letter" for the device, an important step in the approval
process.
Cygnus, Inc. has developed a device known as the GlucoWatch. It is in the form of a wristwatch, but does much
more. It monitors the wearer's blood glucose levels through
electrical impulses up to three times per hour for twelve hours,
all with only one finger-stick measurement for calibration. The
GlucoWatch also includes alarms for highs and lows, and can
detect patterns in glucose levels.
Cygnus submitted an application for pre-market approval from
the FDA. In response, the FDA issued an approval letter. This
states that the FDA believes it will approve the application,
after specific final requests have been met. These conditions
are in regard to aspects of product performance, manufacturing,
and final printed labeling materials.Even so Cygnus states that
it does not expect to put the GlucoWatch on the market until
late this year or early next year.
New Treatment For Diabetic Foot Ulcers
One of the most painful and possibly life-threatening
complication of diabetes are foot ulcers. These
wounds affect 15-20% of people with diabetes, and can lead to
hospitalization and amputation if allowed to progress. A new
form of treatment is now being considered for approval by the
FDA.
The new treatment is called Apligraf, which was used in a study on people who had foot
ulcers as a result of their diabetes. The study included over
200 people, who were either treated with Apligraf and standard
care, or standard care alone. Researchers found that Apligraf
healed 56% of ulcers within twelve weeks, while standard care
alone healed 38% of ulcers. Healing time was also reduced with
Apligraf, and was completed in an average of 65 days, as
compared with the 90 days needed to heal with standard care
alone.
Apligraf is quite similar to actual human skin. It has an
upper epidermal layer, which prompts human epidermal cells to
multiply and differentiate to replicate the actual epidermis. It
also has a lower dermal layer, which contains collagen and human
dermal cells that produce matrix proteins. However, it does not
contain blood vessels, hair follicles, sweat glands, or other
cell types.
Apligraf was developed and is manufactured by Organogenesis
Inc., but they partner with Novartis Pharma AG who owns
exclusive worldwide marketing and distribution rights.
As a result of the study, the General and Plastic Surgery
Devices Panel of the FDA has recommended that Apligraf be
approved for treating diabetic foot ulcers. The recommendation
will be considered when the FDA makes its final decision.
Apligraf has already been approved for treating venous leg
ulcers.
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