Archive for January, 2003

Results from Phase 3 Study - Once Weekly Exenatide LAR

Friday, January 10th, 2003

Good News.

*Once Weekly Exenatide LAR Well Tolerated and Improved Glucose Control;
Preliminary Results From Phase 2 Study Announced*

SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 22,
2005–Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and
Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced
results from the ongoing Phase 2 multi-dose study of a long-acting
release (LAR) formulation of BYETTA(TM) (exenatide) injection in
patients with type 2 diabetes.

The study was designed to assess the safety, tolerability and
pharmacokinetics of exenatide LAR given once a week. After 15 weeks,
both doses of exenatide LAR were well tolerated and expected therapeutic

My intro

Friday, January 10th, 2003

hi my name is Jan,
I am the wife of a diabetic. He has congestive heart failure and has had to have
a below knee amputation ,all due to complications of uncontrolled diabetes.
Only after loosing his leg has he begun to really try to keep it all in line.
he is currently onLantus and Novolog Pen.
We are always looking for new ways to help him. JAN in NC

Thanks Andrew for the link to this group.

Keeping Byetta cold

Thursday, January 9th, 2003

I totally agree, we should all sign up to get the amlyn cooler pack; however
theirs is only designed for a few hours, on the other hand, insulin users
use the frio wallets to keep insulin at proper temp for entire days and
overnight (works up to 3 days I believe), however byetta has to be kept much
colder than insulin and if we are away from refridgeration for any length of
time the amlyn case won’t last long enough.

Recently I travelled and had NO access to a fridge for 72 hours but was able
to keep the byetta at proper temp. I used an insulated lunch bag available
at Wal-Mart for $4.74; the brand name is FROZN. It has an expandable top
and the bottom portion is insulated and contains a small plastic tub that is
removable. I used 3 blue ice packs on the bottom, placed my byetta (in its
box) along with a thermometer in a ziploc on top of the 3 blue ice packs and
then I placed another 3 blue ice packs on top of the byetta. We drove 12+
hours with the a/c not working in our car (hot, hot, hot) and the byetta
(more…)

cold byetta

Wednesday, January 8th, 2003

I spoke with the pharmacist at the Byetta hotline regarding keeping
the medication cold. I had been having a site reaction and thought it
could be due to my Byetta being at room temp. (my mistake)Anyway, she
said it would not breakdown for about seven days if kept at room
temperature (around 72.) She said the most important thing is that it
not be frozen.

I actually have an small, insulated lunch bag that I use with a
freezer pack covered in a dish towel. I got my Byetta welcome kit
yesterday; it has two gel packs to put in the fridge, not freezer. You
put it in the zippered side slotes and put the Byetta pen in the
middle. (The welcome kit took about 6 weeks to arrive.)

Stephanie

something to ponder

Wednesday, January 8th, 2003

Thank you for the Frio info. I wonder how they keep Byetta cold while
shipping it to our pharmacies, and IF it is kept cold enough. YEARS
ago when I worked in a grocery store doing their advertising and
artwork I remember eggs sitting in crates in the back for hours
waiting to be stocked…now with salmonella they were supposed to be
kept refrigerated and I know they weren’t. What assurance do we have
that our Byetta has been kept cold enough before we even get our hands
on it. I’m going to ask my pharmacist at CVS how mine was shipped, by
whom, in what packaging, and how long it took to get there. I am going
to Tasmania, Australia in December..boy that is going to be

Message from Frio about keeping Byetta cold

Wednesday, January 8th, 2003

I am cross-posting this from the byetta blog:

Hello - I am the President of CoolerConcept.com, selling exclusively Frio®
insulin cooling products. We get numerous phone calls and emails each day with
customers wanting to purchase Frio® products to keep their Byetta cool. In my
conversations with Amylin Pharmaceuticals, Byetta MUST be kept between 36°-46°F
at all times. Frio® cooling products will maintain the very safe room
temperature of 68°-72°F, which is the desired room temperatures for insulin. As
a diabetic myself, I understand the frustration of carrying a medication that is
required prior to meals - especially when those meals are not at home, as most
of our lifestyles dictate. We are in business to sell product, but we are also
painfully aware of the cost of these medications and more importantly the
seriousness of keeping diabetes in control.
Before ordering Frio® cooling products for Byetta, please contact your Doctor,
pharmacist or Amylin Pharmaceuticals with the temperatures that Frio® will
(more…)

Some Gila info

Wednesday, January 8th, 2003

Like me most of you have probablly followed the Exendin studies for
MANY (myself 5 years) years now waiting for the drug trials, approval,
etc. I thought maybe any ‘newbees’ might be interested. Added a link
and a picture of our little buddy too under links and photos.

Excerpt from the link:
Gila monsters also have unique physiology to assist them in storing
food for their long periods of inactivity. Immediately after eating,
large quantities of a hormone-like molecule called exendin circulate
in the Gila’s blood. With this unique mechanism of metabolic control,
the act of eating primes the organism to receive the incoming
nutrients, by, for example, stimulating insulin secretion. A synthetic
version of this protein is currently being developed as a treatment
for human diabetes.

(more…)

Thank you All for the help!

Wednesday, January 8th, 2003

Sooo…see I told my doctor I was low at night and NOT snacking..he
thinks I was sleep snacking or something when my sugars are high in
the A.M….thanks for the ammo..an Endocrinologist would probably
know that but I love my doctor and we ‘learn’ together to take care
of the real me. Umami..okay it’s in all the foods I love; meat,
mushrooms,tomatoes,parmesan cheese..yum I’m a Umami freak! Savory
food..yeah! No, I am not just taking Byetta and not eating..but..can
get by with just a peach, or a bit of yogurt and handful of nuts for
hours. Usually do have some egg beaters in some flat bread with
tomatoes and cheese or a Hardee’s low carb breakfast bowl, or a
McDonald’s egg burrito. Have to be sure to eat lunch though before
noon-thirty because the shot is wearing off and if I eat too late my
sugar will edge up towards 200 (180 usually) and don’t want that
when I know with the Byetta it can be 120 after eating. So I just
wait (starving) until I get home and take my 5:00 shot then I can
(more…)

day 3 of week two @5mg

Tuesday, January 7th, 2003

Hello everyone!
Yes Janette I am only taking Byetta and my sugars have normalized,
but really watching what I eat and can only eat smaller amounts at a
time..too full..so I am sure that is helping all in all. I cannot
take glucophage..got lactic acidosis. My renals had shown fine but I
felt like I was dying. Insisted to my doctor (to cure the paranoia
she said I was having) that I wanted the special lactic acid test.
Had it. Had Lactic Acidosis. Last visit to THAT doctor. I can only
take Glipizide which doesn’t do much good, can sort of tolerate
small amounts of Avandia. But since Byetta I am fine without
anything else. Like I said, eating better too but…can eat normally
for the most part now(for Andrew). Pizza will put me to 180 within
an hour of eating it..but two hours and I am down to 130 or less
aaaah..bliss. I am not afraid to eat anything now. Never had donuts
or the like, now can have some if I want..but within the confines of
(more…)

sick day plan

Tuesday, January 7th, 2003

I copied the statement below from a previous post. I totally agree with having
a sick day plan - something I wish my doctor had told me a long time ago.

However, I am finishing a presciption of antibiotics to treat a upper
respiratory infection that also settled in my lungs. Amazingly, the byetta has
kept me under control the entire time I was sick and had a fever - in fact, my
readings ran slightly lower but not hypogycemic. Won’t this be wonderful if it
holds true for others with an infection or illness.

"All the literature says to have a sick day plan. When
you are sick or you have an infection somewhere in your body, your BGs
will go up. How will you get them back down? Your ability to fight off
the illness or infection is greatly affected by your BGs… If they
remain quite high while you are sick, your recovery time will be longer
and your risk of becoming seriously ill increases"