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[IP] buffered insulins for pump use

For the benefit of anyone interested, I'm sharing with
the list some correspondence between myself and  Sofia
A. Iqbal, R.Ph., Drug Information Scientist Associate
at Novo Nordisk, regarding my request for the
availability of a buffered, rapid acting insulin or at
least, a rapid acting insulin alternative to Humalog. 
Choice is a good thing.

 Dear Ms. Krefft,
> Thank you for your recent inquiry concerning insulin
use and the application
> of NovoLog(tm) in external insulin pumps.
> Currently, Velosulin. (human regular buffered
insulin) is the only insulin
> approved by the Food and Drug Administration (FDA)
for pump use.  Velosulin.
> has the same activity profile as Human Regular
insulin except that a buffer
> has been added to decrease the occurrence of pump
and infusion set
> occlusion.  At this time, there is limited
information on the use of other
> insulin types in pumps.  We also can not recommend
the mixing of Humalog.
> and Velosulin. in the pump since Novo Nordisk. has
not conducted any studies
> to assess the response of the mixed product.
> NovoLog(tm) (known as NovoRapid. internationally) is
a rapid-acting human
> insulin analogue which has been approved by the FDA,
but has not yet been
> marketed.  We are anticipating the launch of this
product in the very near
> future.  The product will be available in a 10 mL
vial and 3 mL cartridges.
> At this time, there are no plans to add buffering
agents to NovoLog(tm).
> However, clinical studies have been done and
additional ones are still
> underway to assess the use of NovoLog(tm) in pumps. 
It seems from the
> limited data that has been collected thus far that
NovoLog(tm) can be used
> safely and effectively without pump/infusion set
> We thank you for your suggestion, which has been
forwarded to the Marketing
> and Medical Departments for consideration.  If we
can be of further
> assistance, please do not hesitate to contact us
toll-free at 800-727-6500.
> With best regards,
> Sofia A. Iqbal, R.Ph.
> Drug Information Scientist Associate
> Novo Nordisk Pharmaceuticals, Inc.
> 100 College Road West
> Princeton, NJ 08540
> Tel: (800)727-6500
> email @ redacted

my reply:

Dear Ms. Iqbal,

Thank you so much for responding.  Most of the people
I am in contact
with are using Humalog in their pumps but many, like
my son, have had
infusion site problems with it.  It also, as I think I
may have
mentioned in my first correspondence with you, seems
to foam up at the
leuer lock location.  For this reason, we have been
mixing velosulin and
humalog (5 parts humalog to 1 part velosulin) with
much better results
as far as site longevity is concerned.  And it even
reduces, but does
not eliminate, the foam at the leuer lock.  I
sincerely, hope that
Novolog does not exhibit the same problems with pump
use that Humalog
has shown.  I look forward to using Novolog soon.  Can
you give me a
time frame? I still believe that a buffered Novolog
would be far
superior to anything that's currently out on the
market but even an
unbuffered alternative rapid acting insulin to Humalog
would still be an
improvement compared to what we have now. I was under
the impression
that the only reason we have no choice was because of
Lilly's patent on
Humalog, so a buffered Novolog would have been a
different product,
technically and not subject to the patent issue.

Do you mind if I share your reply below with the
mailing list?  Many people, I'm sure, would find your
letter interesting
and informative.  


Marina Krefft
mom to Mikey age 10 (dxd at age 4)

her reply:

Hello Marina,
> I'm glad you found the information helpful and if
you feel that the
> information may be helpful for your group, then by
all means do share.  If
> they have any additional questions, do not hesitate
to direct them to me or
> our toll free hotline 800-727-6500.  I'm actually
very interested to hear
> what your group might have to share about insulin
use in pumps since we do
> make a pump insulin and are always looking for ways
to improve existing
> products and develop new ones.  Personal experience
information is usually
> very helpful and valuable.  Would you mind if I or
one of our medical
> clinicians joined you in conversation?
> With best regards,
> Sofia

Finally, I also wrote to Eli Lilly but they never

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